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Новини

News and press releases: How to develop vaccines and medicines that prevent and treat respiratory syncytial virus (RSV) infection

New guideline to facilitate development of vaccines and treatments out for consultation until April 2018


News and press releases: EMA gets ready for relocation decision

Close collaboration with new host country as of day one key for successful move


News and press releases: EMA and EUnetHTA finalise joint work plan for 2017-2020

Medicines regulator and network of health technology assessment (HTA) bodies continue to strengthen their collaboration


News and press releases: European Medicines Agency closed 1-3 November 2017

EMA closed from 18:30 on Tuesday 31 October until 7:30 on Monday 6 November


News and press releases: New medicine for multiple sclerosis

Ocrevus is first medicine to receive positive opinion for treatment of patients with early stage of primary progressive multiple sclerosis


News and press releases: Towards a single development programme for new antibiotics in EU, Japan and US

EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development


News and press releases: New EudraVigilance system is live

Better safety monitoring for patients across Europe


News and press releases: EMA to relocate to Amsterdam, the Netherlands

Agency to begin working immediately with Dutch government to ensure successful move by end of March 2019


News and press releases: ENCePP: 10 years for excellence in medicines safety

Key achievements after 10 years of collaboration


News and press releases: New guidelines on good manufacturing practices for advanced therapies

Adaptations ensure a high level of quality for ATMPs and patient protection


EudraVigilance information day, European Medicines Agency, London, UK, From: 15-Dec-2017, To: 15-Dec-2017

This EudraVigilance information day provides a forum to discuss the very initial experience of stakeholders with the new EudraVigilance system functionalities following its launch in November 2017, the use of the new ICH E2B(R3) standard, the simplified adverse reaction reporting and the data analysis outputs. The Information Day will also serve as a platform to experts to raise questions on the practical application of the recently revised GVP Modules VI and IX.


Second industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 15-Nov-2017, To: 15-Nov-2017

This is the second event in a series of (semi-)annual meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of product development support, from scientific advice, over specifics for paediatric and orphan medicines and to innovation support. This platform aims to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. Registration by invitation only.


eXtended EudraVigilance medicinal product dictionary face-to-face training course, Prague, Computer Help, Prague, Czech Republic, From: 09-Apr-2018, To: 10-Apr-2018

The European Medicines Agency (EMA) has prepared this eXtended EudraVigilance medicinal product dictionary (XEVMPD) face-to face training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU. The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.


eXtended EudraVigilance medicinal product dictionary face-to-face training course, European Medicines Agency, London, UK, From: 15-Feb-2018, To: 16-Feb-2018

The European Medicines Agency (EMA) has prepared this eXtended EudraVigilance medicinal product dictionary (XEVMPD) face-to face training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU. The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.


eXtended EudraVigilance medicinal product dictionary face-to-face training course, Madrid, Aula Center, Madrid, Spain, From: 07-Jun-2018, To: 08-Jun-2018

The European Medicines Agency (EMA) has prepared this eXtended EudraVigilance medicinal product dictionary (XEVMPD) face-to face training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU. The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.


eXtended EudraVigilance medicinal product dictionary face-to-face training course, European Medicines Agency, London, UK, From: 21-Jun-2018, To: 22-Jun-2018

The European Medicines Agency (EMA) has prepared this eXtended EudraVigilance medicinal product dictionary (XEVMPD) face-to face training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU. The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.


Workshop on site and histology - Independent indications in oncology, European Medicines Agency, London, UK, From: 14-Dec-2017, To: 15-Dec-2017

Biological drivers that define cancer course across anatomical sites and histologies offer an opportunity to select populations sensitive to specific drugs based on those drivers, independently of the specific site or histology. This workshop aims to provide an exchange of views from different stakeholders about situations where a site and histology-independent clinical development might be a viable option and the associated challenges in terms of drug development, benefit-risk evaluation and health-technology assessment.


Training session for patients and consumers interested in European Medicines Agency activities, European Medicines Agency, London, UK, From: 21-Nov-2017, To: 21-Nov-2017

This one-day training session for representatives of patients' and consumers' and healthcare professionals’ organisations aims at presenting an overview of medicines evaluation with specific emphasis on where and how they can be involved. Using a hands-on interactive approach, participants will learn more about how they can contribute to scientific advice procedures, Scientific Advisory Group (SAG) meetings and in review of information for patients.


European Medicines Agency Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting with all eligible organisations, European Medicines Agency, London, UK, From: 22-Nov-2017, To: 22-Nov-2017

This final meeting for 2017 brings together members of the Patients and Consumers Working Party (PCWP) with all eligible patient and consumer organisations. Topics for discussion include highlights from 2017, feedback on EMA’s first public hearing, some new EMA shareable communications, big data and real world evidence, EMA Action Plan following Commission’s recommendations on product information and EMA’s new EPAR summary template. Other topics for discussion include the PCWP and HCPWP work plans and topic groups for 2018/19, scientific committees’ feedback and Members’ voice. Participants will also be updated on relocation preparedness.


Third tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents, Kyoto, Japan, From: 24-Nov-2017, To: 25-Nov-2017

This meeting built on the work of previous two meetings between the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in the way these regulators approach the evaluation of antimicrobials, aiming at identifying further areas for convergence. The three agencies agreed to further align how clinical trials should be designed to study the effects of new antibiotics in certain indications, such as uncomplicated gonorrhoea or uncomplicated urinary tract infections. They also committed to working together to explore how to better streamline paediatric development of new antibacterial agents and discussed he importance of characterising the pharmacokinetic-pharmacodynamic relationship and monitoring the benefit-risk balance throughout the medicine lifecycle. The agencies plan to meet again in 2018.


Innovation and biomarkers in cancer drug development (IBCD) 2018, Brussels, Belgium, From: 29-Nov-2018, To: 30-Nov-2018

The innovation and biomarkers in cancer drug development (IBCD) 2018 event will embrace the full environment and explore routes through the constantly evolving scientific, methodological and regulatory environment. The combined efforts of the European Organisation for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI), European Medicines Agency (EMA), and American Association for Cancer Research (AACR) with the involvement of Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) and health technology assessment specialists will result in a unique program. The 2018 edition will build upon the recommendations and action points decided upon at the IBCD 2016 edition. Topics, which will be developed, will include items like health technology assessment (HTA) of biomarker assays, comparative effectiveness research and the translation of findings of clinical trials into daily practice.


Introduction to the European Union regulatory system and European Medicines Agency for international regulators and non-governmental organisations, European Medicines Agency, London, UK, From: 18-Sep-2017, To: 19-Sep-2017

This two-day awareness session is for international regulators and non-governmental organisations. It gives an insight into the European Union (EU) regulatory system for medicines and the role of the European Medicines Agency (EMA). Insight into the EU system is of prime importance in an increasingly globalised world where worldwide regulators rely on close cooperation. The EU system is one of the most advanced in the world, but it is also one of the most complex. It is based on a network of decentralised agencies in the EU Member States, supported and coordinated by EMA.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Madrid, Aula Center, Madrid, Spain, From: 04-Jun-2018, To: 06-Jun-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Amsterdam , BCN Amsterdam Arena, Amsterdam, The Netherlands, From: 19-Mar-2018, To: 21-Mar-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Paris, Châteauform’ College, Paris, France, From: 13-Jun-2018, To: 15-Jun-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Prague, Computer Help, Prague, Czech Republic, From: 11-Apr-2018, To: 13-Apr-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Athens, OTE Academy, Athens, Greece, From: 21-Feb-2018, To: 23-Feb-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Lisbon, Infarmed, Lisbon, Portugal, From: 22-Jan-2018, To: 24-Jan-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Vienna, Austrian Agency for Health and Food Safety (AGES), Vienna, Austria, From: 05-Feb-2018, To: 07-Feb-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Berlin, one-by-one EDV-GmbH, Berlin, Germany, From: 15-Jan-2018, To: 17-Jan-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 10-Jan-2018, To: 11-Jan-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 30-May-2018, To: 01-Jun-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 29-Jan-2018, To: 31-Jan-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 16-Apr-2018, To: 18-Apr-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 12-Feb-2018, To: 14-Feb-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 28-May-2018, To: 30-May-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 18-Jun-2018, To: 20-Jun-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 23-Apr-2018, To: 25-Apr-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


European Medicines Agency information day on risk management planning: implementation of GVP V and RMP template rev. 2 guidance, European Medicines Agency, London, UK, From: 19-Dec-2017, To: 19-Dec-2017

This information day is aimed primarily at providing marketing authorisation holders and marketing authorisation applicants with practical advice on risk management plans (RMP) drafting using the principles of risk assessment and management included in good pharmacovigilnce practice (GVP) module V rev. 2. Content requirements and procedural advice for RMP submission will be presented with practical examples provided, based on frequent questions from applicants, assessors, and European Medicines Agency (EMA) Risk Management Specialists. Highlights will include types of products with different legal basis application (e.g. generics, fixed dose combination products, biosimilars). Feedback from the industry will be discussed and EMA and Pharmacovigilance Risk Assessment Committee (PRAC) view on topics raised will be provided. The Q&A and panel discussion sessions will include the response to questions received in advance or raised during the presentations.


Fourth industry stakeholder platform on the operation of the centralised procedure for human medicines, European Medicines Agency, London, UK, From: 03-Jul-2017, To: 03-Jul-2017

The objective of these platform meetings is to foster a constructive dialogue with industry stakeholders on operational matters of the centralised procedure and to identify opportunities for improvement. The focus of this fourth meeting is the outcome of the tripartite survey by rapporteurs, industry and the European Medicines Agency on initial marketing authorisation applications. Other topics include an exchange of experience with the new accelerated assessment process and the new linguistic review process, share experience with the use of the effects table to support benefit-risk discussions and to get industry feedback on some important updates in our post-authorisation procedures.


SME info day: supporting innovative medicines' development and early access, European Medicines Agency, London, UK, From: 17-Nov-2017, To: 17-Nov-2017

The info day provides an overview of EU initiatives supporting development stage small and medium-sized enterprises in the human medicines field. It highlights future EU funding opportunities and platforms for early regulatory dialogue with the European Medicines Agency (EMA) and the EU network. It covers recent developments in scientific advice, the range of support that companies can access to optimise their development plans, and feedback on experience at stage of the marketing authorisation. It is organised in collaboration with the newly launched EU Innovation Network, a platform created to support pharmaceutical innovation both at national and EU level. In the breaks the “Meet the EU Innovation Network Regulators” event will provide an opportunity to engage with its representatives. An update on Brexit related activities will also be provided. The info day is open to companies that have been assigned an SME status by EMA and to representatives of stakeholder organisations.


Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2017, European Medicines Agency, London, UK, From: 27-Nov-2017, To: 30-Nov-2017

The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.


News and press releases: Guidance to help pharma companies prepare for Brexit

Additional guidance relates to medicines for human and veterinary use


Data anonymisation workshop , European Medicines Agency, London, UK, From: 30-Nov-2017, To: 01-Dec-2017

The data anonymisation workshop focuses on anonymisation as a key enabler for clinical data sharing. The scope of the workshop includes clinical trial data including individual patient level data and real world data in the context of patient registries and individual cohort studies.


Management Board meeting: 5 October 2017, European Medicines Agency, London, UK, From: 05-Oct-2017, To: 05-Oct-2017

The Management Board is an integral governance body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency’s performance.


Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications, European Medicines Agency, London, UK, From: 23-Nov-2017, To: 23-Nov-2017

The term ‘prior knowledge’ can refer to both a company’s proprietary knowledge of formulation and manufacturing development of medicinal products and external knowledge from published scientific literature. The use of such prior knowledge to support the development of product formulations, manufacturing processes and control strategies, could be justifiable in certain circumstances. Through a combination of presentations, industry case studies and panel discussions, this joint workshop with regulators and the pharmaceutical industry aims to reach an agreed understanding on what is (and isn’t) considered to be prior knowledge, how can such prior knowledge be used in regulatory submissions, how to justify its use and how to present it in the dossier. EMA will publish a report with conclusions from the workshop. It may also consider further follow-up guidance.


News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 December 2017

CVMP adopts revised guidance on use of pictograms and QR codes in packaging for veterinary medicinal products


News and press releases: First guidance on monoclonal antibodies for use in animals

Guidance supports development of novel veterinary therapies


Fourteenth joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting , European Medicines Agency, London, UK, From: 15-Dec-2017, To: 15-Dec-2017

The EMA and EUnetHTA have been holding regular dialogue since 2010. The key topics of this meeting are concepts related to orphan medicines (significant benefit vs relative effectiveness), opportunities for collaboration on horizon scanning, reflections on the concept of evidence transfer / extrapolation, principles of the working of the indication as well as ongoing initiatives on post-licensing evidence generation. A report from the meeting will be published later.


The New EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(R3) format: hands-on training course, Zagreb, Croatia, From: 14-May-2018, To: 16-May-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The New EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(R3) format: hands-on training course, Bucharest, Romania, From: 26-Feb-2018, To: 28-Feb-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI 'Management and reporting of adverse reactions to medicinal products' and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


News and press releases: Mycophenolate: updated recommendations for contraception for men and women

Recommendations updated to reflect level of risk to unborn babies following organ transplantation


News and press releases: EMA Management Board: highlights of December 2017 meeting

Brexit update and adoption of work programme and budget for 2018


News and press releases: New medicine for rare bone disease

Crysvita, a medicine for the treatment of X-linked hypophosphataemia, recommended for conditional approval


News and press releases: New medicine to treat perianal fistulas in patients with Crohn’s disease

Alofisel is the tenth advanced therapy recommended for marketing authorisation


News and press releases: First paediatric medicine to treat rare hormonal disorder

CHMP gives positive opinion to Alkindi for paediatric-use marketing authorisation


News and press releases: European Commission closes infringement procedure against Roche

Decision follows EMA inquiry on company’s compliance with its pharmacovigilance obligations


Management Board meeting: 13-14 December 2017, European Medicines Agency, London, UK, From: 13-Dec-2017, To: 14-Dec-2017

The Management Board is an integral governance body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency’s performance.


Second international awareness session for international regulators, academia and non-governmental organisations, European Medicines Agency, London, UK, From: 08-Mar-2018, To: 09-Mar-2018

This two-day awareness session for international regulators and non-governmental organisations (NGOs) will give an insight into how the European medicines regulatory network works, the role of European Medicines Agency (EMA), scientific aspects of EMA's work and its interaction with scientific experts. It will address topics including the role of experts and benefit-risk evaluation. It will also provide networking opportunities with academics, NGOs staff and regulators from and outside the European Union. The event will be broadcast live. EMA will publish further material after the event.


European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 25-Oct-2017, To: 25-Oct-2017

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group (CG) in 2017 welcomed members of the working groups and representatives of the registered networks. The focus of this meeting was on updates from the working groups on their work since the last update during the face to face 22017 annual workshop of the European network of paediatric research at the European Medicines Agency. The CG also reviewed proposals for the pam-European IMI2 paediatric network and contributions to the public consultation on the reflection pager on the use of extrapolation of efficacy and safety in medicine development.


European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 22-Nov-2017, To: 22-Nov-2017

The last meeting of the European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group in 2017 saw the review of the mandate of the working groups, the endorsement to new network members. The group also discussed the agenda of the 2018 face to face meeting.


Meeting with Alliance for Regenerative Medicine, European Medicines Agency, London, UK, From: 14-Dec-2017, To: 14-Dec-2017

This meeting was organised at the request of the Alliance for Regenerative Medicines organisation (AMR). The purpose of the meeting was to gain insight into and understanding of the role and responsibilities of the European Medicines Agency and to discuss areas of common interest.


News and press releases: European Medicines Agency closed 22 December 2017 to 2 January 2018

EMA closed from 18:30 on Thursday 21 December 2017 until 7:30 on Wednesday 3 January 2018


European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / substance, product, organisation and referential data (SPOR) task force meeting, European Medicines Agency, London, UK, From: 20-Oct-2017, To: 20-Oct-2017

The European Union (EU) International Organisation for Standardization (ISO) identification of medical products (IDMP) / substance, product, organisation and referential (SPOR) data task force meeting with representatives from the European Medicines Agency, national competent authorities, pharmaceutical industries associations, terminology organisations, software vendors and developers of medicinal products dictionaries / databases discusses aspects of planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.


News and press releases: Orphan medicines in the EU – leaving no-one behind

An overview of the EU’s orphan designation programme


Committee for Herbal Medicinal Products (HMPC): 18-19 September 2017, European Medicines Agency, London, UK, From: 18-Sep-2017, To: 19-Sep-2017

The Committee on Herbal Medicinal Products (HMPC) is the committee that is responsible for preparing the Agency’s opinions on questions relating to herbal medicines.


Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 November 2017, European Medicines Agency, London, UK, From: 07-Nov-2017, To: 09-Nov-2017

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.


Twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union, European Medicines Agency, London, UK, From: 24-Nov-2017, To: 24-Nov-2017

The twelfth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system.


A common data model in Europe? – Why? Which? How?, European Medicines Agency, London, UK, From: 11-Dec-2017, To: 12-Dec-2017

This meeting will aim to define the opportunities and challenges in applying a common data model in Europe to support regulatory decision-making and agree guiding principles for the development of such a model, including key criteria for validation in the context of regulatory decision-making. A common data model could help harmonise healthcare data across multiple data sets and provide a mechanism to conduct pan-European studies in a timely manner to address regulatory questions. At the same time, applying a common model to European data has multiple challenges. The meeting will bring together regulators with academia, data holders and the pharmaceutical industry.


News and press releases: PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market

Review finds measures to protect patients have not been sufficiently effective


News and press releases: Defect with Buccolam oral syringes

Translucent cap may remain attached to syringe – parents and carers advised to inspect the syringe before use


News and press releases: Is an orphan medicine still an orphan once it gets on the market?

EMA publishes additional reports on decision-making for orphan medicines; initiative addresses requests from stakeholders


News and press releases: Human medicines: highlights of 2017

92 medicines recommended for approval, including 35 with a new active substance


News and press releases: Why EMA matters to European citizens

Three videos launched today to explain what EMA is and how it works to help patients


News and press releases: EMA surveys pharma companies on their preparedness for Brexit

Planning of regulatory steps needed to ensure medicines remain on EU market


Chimeric antigen receptor (CAR) T-cell therapy registries workshop, European Medicines Agency, London, UK, From: 02-Sep-2018, To: 02-Sep-2018

The objective of this workshops is to facilitate the long-term follow up of CAR-T cell products in a real world setting and enable the generation of meaningful efficacy and safety data using haemato-oncological registries. It will aim to agree on implementable recommendations on core data elements to collect and other matters including patient consent, governance, quality assurance and registry interoperability as well as recommendations to optimise collaboration among registry holders, marketing authorisation holders and applicants and regulators.


News and press releases: Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation

Suspension due to serious risks of kidney injury and death in certain patient populations


Veterinary innovation day, European Medicines Agency, London, UK, From: 19-Apr-2018, To: 19-Apr-2018

The purpose of the European Medicines Agency (EMA) veterinary innovation day is to raise awareness and promote the support and measures that the Agency has to offer in the area of veterinary medicines innovation. The event is aimed at industry, including micro, small and medium-sized enterprises (SMEs) and veterinary consultants. The information provided will also be beneficial to academia, veterinary healthcare professionals and national competent authorities.


News and press releases: Statement by Executive Director Guido Rasi in The Hague

EMA relocation project – press conference with Dutch authorities


News and press releases: How to better apply the paediatric legislation to boost development of medicines for children

EMA and European Commission invite stakeholders to register for joint workshop and support development of an action plan


Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation, European Medicines Agency, London, UK, From: 20-Mar-2018, To: 20-Mar-2018

This workshop, organised by the European Medicines Agency (EMA) and the European Commission, follows the publication of the Commission’s ten-year report on implementation of the Paediatric Regulation and the state of paediatric medicines in the European Union. The aim is to discuss potential improvements of the implementation of the Regulation. It will explore opportunities regarding paediatric needs, timely completion of paediatric investigation plans (PIP), and processes and expectations for handling PIP applications. This workshop is a crucial step for the development of a concrete action plan to address challenges identified with medicine development for children in Europe. Invited stakeholders include patients, academia, healthcare professionals and industry. The deadline for expressions of interest is 14 February. EMA will select industry stakeholders via registered associations. The Agency will contact all selected participants on 1 March.


News and press releases: Evaluation of advanced therapy medicines

Updated procedural advice clarifies regulatory process for advanced therapy medicinal products


News and press releases: Strengthened guidance on follow-up and risk management for ATMP developers

Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultation


News and press releases: General Court confirms EMA approach to transparency

Three rulings clarify the scope of commercial confidentiality with regard to authorised medicines


Extraordinary Management Board meeting: 6 February 2018, European Medicines Agency, London, UK, From: 06-Feb-2018, To: 06-Feb-2018

The Management Board is an integral governance body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency’s performance.


Industry associations webinar: update on the implementation of European Medicines Agency policy on publication of clinical data - Policy 0070, European Medicines Agency, London, UK, From: 29-Jan-2018, To: 29-Jan-2018

The European Medicines Agency is holding a webinar with industry associations. The objective of this meeting is to update the industry associations and to receive their feedback on the implementation of the Clinical Data Publication (Policy 0070).


Paediatric Committee (PDCO): 23-26 January 2018, European Medicines Agency, London, UK, From: 23-Jan-2018, To: 26-Jan-2018

The Paediatric Committee (PDCO) is the committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.


News and press releases: PRAC recommends new measures to avoid valproate exposure in pregnancy

New restrictions on use; pregnancy prevention programme to be put in place


News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2018

PRAC gives recommendations for valproate, flupirtine, retinoids and interim advice for Esmya


News and press releases: Veterinary medicines: highlights of 2017

18 medicines recommended for marketing authorisation, including ten vaccines


Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 February 2018, European Medicines Agency, London, UK, From: 13-Feb-2018, To: 15-Feb-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.


Update on Brexit regulatory preparedness activities for veterinary companies , European Medicines Agency, London, UK, From: 20-Apr-2018, To: 20-Apr-2018

The European Medicines Agency (EMA) is holding this meeting to give an update on EMA Brexit preparedness activities and address any specific questions industry stakeholders may have further to the publication of European Commission and EMA questions and answers document and EMA procedural guidance. This event is specifically targeting small and medium enterprises’ needs (SMEs) but is also open to all companies and stakeholders developing veterinary medicinal products.


News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 February 2018

CVMP recommends changes to product information for some veterinary medicines containing enrofloxacin, to reduce development of antimicrobial resistance in target pathogens


EMA EudraVigilance and signal management information day, European Medicines Agency, London, UK, From: 16-Mar-2018, To: 16-Mar-2018

This EudraVigilance information day provides a forum to discuss the initial experience of stakeholders with the new EudraVigilance system functionalities focusing on procedural, technical and data quality aspects and the use of the new ICH E2B (R3) standard. In addition, this information day will allow the audience to interact with signal management experts from EMA and national competent authorities and to learn from the approach of marketing authorisation holders involved in the pilot.


News and press releases: First medicine to treat neonatal diabetes

Amglidia is a new formulation of glibenclamide, specifically developed for use in newborns, toddlers and children


News and press releases: New treatment option for rare inflammatory disease

Extension of indication of Kineret for Still’s disease in children and adults


News and press releases: Towards more ethical use of animals in medicine testing

First report on EMA’s actions to replace, reduce, refine use of animals in medical research


Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 January 2018, European Medicines Agency, London, UK, From: 16-Jan-2018, To: 18-Jan-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.


Substance, product, organisation and referential data (SPOR) impact on veterinary stakeholders, European Medicines Agency, London, UK, From: 20-Feb-2018, To: 20-Feb-2018

The European Medicines Agency (EMA) held a webinar with veterinary medicines stakeholders, comprising national competent authorities and industry associations, to raise awareness of substance, product, organisation and referential (SPOR) data services and identify challenges related to the implementation of the SPOR programme.


Submission of referentials management services (RMS) and organisations management services (OMS) change requests, European Medicines Agency, London, UK, From: 12-Feb-2018, To: 12-Feb-2018

The European Medicines Agency’s (EMA) programme for substance, product, organisation and referential (SPOR) data services held a webinar with industry stakeholders to summarise the milestones and impacts on industry of the referentials management services (RMS) and organisations management services (OMS). The webinar focused on the submission of RMS and OMS change requests relating to referential and organisation data.


News and press releases: Revised guideline on clinical studies for Alzheimer’s disease medicines

Guidance expected to facilitate development of medicines to prevent and treat condition


Extraordinary Management Board meeting: 28 February 2018, Lisbon, Portugal, From: 28-Feb-2018, To: 28-Feb-2018

This extraordinary Management Board meeting is to consider the building approval process for EMA’s premises in Amsterdam. The Management Board is an integral governance body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency’s performance.


Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products, European Medicines Agency, London, UK, From: 23-Mar-2018, To: 23-Mar-2018

The purpose of this meeting is to update European Union trade associations on the Agency's Brexit preparedness activities.


News and press releases: New tracking tool for EMA’s relocation to Amsterdam

Tool gives transparent overview of main milestones and work stream deliverables


Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018, European Medicines Agency, London, UK, From: 05-Mar-2018, To: 08-Mar-2018

The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.


SPOR data services: questions and answers webinar with industry, European Medicines Agency, London, UK, From: 07-Dec-2017, To: 07-Dec-2017

The European Medicines Agency (EMA) held a webinar with industry stakeholders. The objective of the event was to provide a summary of SPOR data services, outline the impacts of intergation of OMS and RMS with the eAF, and to provide an opportunity for participants to ask questions.


Using Organisations Management Services (OMS) and Referentials Management Service (RMS) data in electronic application forms (eAF): SPOR webinar, European Medicines Agency, London, UK, From: 28-Nov-2017, To: 28-Nov-2017

The European Medicines Agency (EMA) held a webinar with industry stakeholders and eAF users. The objective of the event was to raise awareness of SPOR data services, outline how the Referentials and Organisation data will be used in the version of the eAF, that went live in December 2017, and what are the impacts on the users.


News and press releases: Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone

Ongoing clinical study shows an increased risk of death and fractures with the combination


News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 March 2018

Immediate measures agreed for Zinbryta and Xofigo while reviews are ongoing; public hearing decided for quinolone and fluoroquinolone antibiotics


Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2018, European Medicines Agency, London, UK, From: 19-Feb-2018, To: 22-Feb-2018

The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines.


Thirteenth industry stakeholder platform - operation of EU pharmacovigilance , European Medicines Agency, London, UK, From: 20-Mar-2018, To: 20-Mar-2018

The thirteenth platform meeting with industry stakeholder associations on the operation of the European pharmacovigilance system will take place at the European Medicines Agency on 20 March 2018. Discussions will focus on the new EudraVigilance system and the pilot of MAHs EudraVigilance signal detection.


Management Board meeting: 15 March 2018, European Medicines Agency, London, UK, From: 15-Mar-2018, To: 15-Mar-2018

The Management Board is an integral governance body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency’s performance.


Committee for Advanced Therapies (CAT): 14-16 March 2018, European Medicines Agency, London, UK, From: 14-Mar-2018, To: 16-Mar-2018

The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.


News and press releases: EMA Management Board: highlights of March 2018 meeting

Board adopts 2017 report on veterinary medicines for minor use minor species and hears update on clinical trial portal and database


News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 March 2018

CVMP recommends modification of the MRL for diflubenzuron in Salmonidae


News and press releases: Withdrawal of pain medicine flupirtine endorsed

Serious liver problems continued to be reported despite previous restrictions in use


News and press releases: Colour change for insulin injection Fiasp to avoid mix ups with Tresiba

Cartridges, pre-filled pens and vials changing from yellow to red and yellow


News and press releases: Updated measures for pregnancy prevention during retinoid use

Warning on possible risk of neuropsychiatric disorders also to be included for oral retinoids


News and press releases: New measures to avoid valproate exposure in pregnancy endorsed

Member State representatives agree new restrictions and pregnancy prevention programme


News and press releases: European Medicines Agency closed 29 March to 2 April 2018

EMA closed from 18:30 on Wednesday 28 March 2018 until 7:30 on Tuesday 3 April 2018


Haemophilia registries workshop, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

The objective of this workshop is to ensure the practical implementation of the requirements related to patient registries for haemophilia medicinal products in Europe, in line with the draft revision of the Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products. The aim is to agree on the use of registry data for regulatory purposes for haemophilia medicinal products in terms of data access and data sharing/reporting between all involved stakeholders, including patients, physicians, registry holders, marketing authorisation holders/applicants, regulatory authorities and health technology assessment bodies. In addition the additional data elements that could be collected by registries for novel products (such as gene therapy, PEGylated medicinal products and monoclonal antibodies) will be discussed as well as quality of life elements. This call for expressions of interest is open until 13th April.


European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 17-Apr-2018, To: 18-Apr-2018

During the first day of the meeting digital media and health topics will be discussed, including recent learnings and trends around mHealth, social media, real-word evidence and electronic product information. On the second day, PCWP/HCPWP members will have a chance to hear the latest on EMA relocation, clinical data publication policy and implementation of Clinical Trial Regulation; followed by discussion on findings of the survey on “additional monitoring” awareness. Other topics for discussion include EMA-Heads of Medicines Agencies (HMA) collaboration on shortages and availability of medicines and EMA- European network for health technology assessment (EUnetHTA) collaboration on engagement with patients and healthcare professionals in assessment activities.


Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: Identifying solutions for big data challenges, European Medicines Agency, London, UK, From: 04-May-2018, To: 04-May-2018

The aim of this workshop is to inform thinking on big data and related challenges as the HMA/EMA Joint Big Data Task Force is planning to make recommendations in this field in November 2018. In 2017, the task force undertook detailed landscaping of the entire big data field (genomics through to m-health) as viewed through the lens of the regulator. It also performed online surveys of both national regulatory agencies and the pharmaceutical industry on perspectives, expertise and challenges. This work helped develop an understanding of the challenges and the current state of expertise in the regulatory network. The taskforce now aims to move onto considering solutions. The task force was established in March 2017 to identify the emerging challenges created by the increasing availability of data and related opportunities for supporting regulatory decision-making.


News and press releases: Public hearing on 13 June 2018

Citizens to be consulted on quinolone and fluoroquinolone antibiotics


Committee for Herbal Medicinal Products (HMPC): 26-27 March 2018, European Medicines Agency, London, UK, From: 26-Mar-2018, To: 27-Mar-2018

The Committee on Herbal Medicinal Products (HMPC) is the committee that is responsible for preparing the Agency’s opinions on questions relating to herbal medicines.


Committee for Orphan Medicinal Products (COMP): 17-19 April 2018, European Medicines Agency, London, UK, From: 17-Apr-2018, To: 19-Apr-2018

The Committee for Orphan Medicinal Products (COMP) is the committee that is responsible for reviewing applications for 'orphan medicinal product designation' for medicines intended for the diagnosis, prevention or treatment of rare diseases.


Committee for Medicinal Products for Veterinary Use (CVMP): 17-19 April 2018, European Medicines Agency, London, UK, From: 17-Apr-2018, To: 19-Apr-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.


Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients, European Medicines Agency, London, UK, From: 05-Sep-2018, To: 06-Sep-2018

The third multi-stakeholder Paediatric Strategy Forum, jointly organised by EMA and ACCELERATE will focus on checkpoint inhibitors used in combination therapy, in children and adolescents. This Forum will reviewed the immunological environment of paediatric malignancies, checkpoint inhibitors in early phase clinical studies in paediatrics, strategies combining checkpoint inhibitors with other products and alternative immunotherapy strategies. Participation is restricted and on invitation only. Interested parties, including patients and parent-representatives, academia, clinicians and industry, should express their interest using the forms linked to this page.


News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-19 April 2018

CVMP adopts new guideline on user safety of topically applied veterinary medicines


Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 March 2018, European Medicines Agency, London, UK, From: 13-Mar-2018, To: 15-Mar-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.


News and press releases: Ten years promoting high-quality scientific research in paediatric medicines

Registration opens for workshop of the European Network of Paediatric Research at EMA (Enpr-EMA), 7–8 June 2018


2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research networks, learned societies, national paediatric associations/societies, ethics committees, regulators, Health Technology Assessment bodies and industry); and ii) an interactive general discussion on how to avoid duplication of trials, how to improve communication, how to divide work between groups and on the challenges of clinical trials in (ultra) rare diseases. The following day is reserved for discussions among the members of Enpr-EMA.


News and press releases: Updated rules for clinical development of vaccines

EMA launches public consultation on revised guideline on clinical evaluation of vaccines


News and press releases: European Medicines Agency closed 1 May 2018

EMA closed from 18:30 on Monday 30 April until 7:30 on Wednesday 2 May 2018


Eleventh stakeholder forum on the pharmacovigilance legislation, European Medicines Agency, London, UK, From: 21-Sep-2017, To: 21-Sep-2017

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.


News and press releases: EMA 2017 annual report published

Report highlights major achievements and includes key figures


Committee for Advanced Therapies (CAT): 15-16 February 2018, European Medicines Agency, London, UK, From: 15-Feb-2018, To: 16-Feb-2018

The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.


News and press releases: European Medicines Agency closed 9-11 May 2018

EMA closed from 18:30 on Tuesday 8 May until 7:30 on Monday 14 May 2018


News and press releases: Two years of PRIME

Driving innovation to where it is most needed


Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018, European Medicines Agency, London, UK, From: 14-May-2018, To: 17-May-2018

The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.


Info day for micro, small and medium-sized enterprises: regulatory toolbox for medicines and combined devices, European Medicines Agency, London, UK, From: 26-Oct-2018, To: 26-Oct-2018

The SME info day provides an update on regulatory affairs topics for developers of human medicines and combined devices. It covers subjects such as data exclusivity and market protection, orphan and paediatric rewards, legal basis for submission of a marketing authorisation application, conditional marketing authorisations and approvals under exceptional circumstances, classification of advanced therapies and EMA activities in relation to the new medical device legislation. An update on Brexit-related activities will also be provided at the end of the event. The 'Meet EMA' event will provide an opportunity for SMEs to engage with EMA staff from different departments to increase awareness of the range of support available at EMA. The event is open to companies that have been assigned SME status by EMA and to representatives of stakeholder organisations. It will be broadcast and recorded for interested parties to follow the proceedings.


Paediatric Committee (PDCO): 20-23 March 2018, European Medicines Agency, London, UK, From: 20-Mar-2018, To: 23-Mar-2018

The Paediatric Committee (PDCO) is the committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.


News and press releases: European Medicines Agency closed 21 May 2018

EMA closed from 18:30 on Friday 18 May until 7:30 on Tuesday 22 May 2018


News and press releases: EMA review of Zinbryta confirms medicine’s risks outweigh its benefits

Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies


News and press releases: New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir

While EMA review is ongoing, dolutegravir should not be used in women seeking to become pregnant


News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 May 2018

PRAC concludes two referrals, maintains recommendation on HES solutions for infusion and issues precautionary advice on HIV medicine


Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third meeting of the industry stakeholder platform on research and development support This is the third event in a series of (semi-) annual meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of product-development support, from scientific advice, through specifics for paediatric and orphan medicines, to innovation support. This meeting will focus on the implementation of the Orphan notice, “histology-independent indications” in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine development programmes, co-development with companion diagnostics as well as cross-decision maker collaboration in the space of horizon scanning activities. Furthermore, it provides an opportunity to provide updates on activities in the space of post-licensing evidence generation, paediatric medicines and PRIME.


News and press releases: Working together for people with rare and complex diseases

Live broadcast of workshop with European Reference Networks on 29 May


EMA / RD-ACTION / DG SANTE workshop: how European Reference Networks can add value to clinical research, European Medicines Agency, London, UK, From: 29-May-2018, To: 30-May-2018

The main objective of this workshop organised by the European Medicines Agency (EMA), RD-ACTION (the European Joint Action for Rare Diseases) and the European Commission’s Directorate General for Health and Food Safety (DG SANTE), is to explore how to work together with the European Reference Networks (ERNs) in the field of complex and rare diseases. The workshop will look at how EMA and ERNs can reinforce each other’s efforts to encourage and facilitate research into new treatments for rare and low-prevalence complex diseases and how ERNs could be engaged in EMA activities. The first ERNs were launched in March 2017, involving more than 900 highly-specialised healthcare units from over 300 hospitals in 26 European Union countries. Presently, 24 ERNs are operational covering a large range of therapeutic areas.


Committee for Medicinal Products for Veterinary Use (CVMP): 23-25 May 2018, European Medicines Agency, London, UK, From: 23-May-2018, To: 25-May-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.


News and press releases: Development of antibiotics for children - towards a global approach

Workshop with regulators from EU, Japan and US open for registration


Workshop on the development of antimicrobial medicinal products for paediatric patients, European Medicines Agency, London, UK, From: 21-Jun-2018, To: 22-Jun-2018

The European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency and the United States' Food and Drug Administration are co-organising this workshop to discuss the development of antibiotics for children. This will provide an opportunity for international regulators to explore with medicine developers, clinicians and clinical trial investigators, clinical development plans that would allow for the timely development of antibiotics for children and discuss a regulatory pathway for their approval. Please send expressions of interest to attend the workshop by 6 June 2018.


Committee for Advanced Therapies (CAT): 23-25 May 2018, European Medicines Agency, London, UK, From: 23-May-2018, To: 25-May-2018

The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.


News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018

New vaccine to reduce the incidence of intramammary infections in cows/heifers recommended for approval


Paediatric Committee (PDCO): 29 May – 1 June 2018, European Medicines Agency, London, UK, From: 29-May-2018, To: 01-Jun-2018

The Paediatric Committee (PDCO) is the committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.


Committee for Orphan Medicinal Products (COMP): 22-24 May 2018, European Medicines Agency, London, UK, From: 22-May-2018, To: 24-May-2018

The Committee for Orphan Medicinal Products (COMP) is the committee that is responsible for reviewing applications for 'orphan medicinal product designation' for medicines intended for the diagnosis, prevention or treatment of rare diseases.


News and press releases: Construction of new EMA building in Amsterdam on track

Foundation stone-laying ceremony takes place at Zuidas


European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

The 2018 face-to-face meeting of Enpr-EMA networks and coordinating members takes place after the annual open workshop on 8 June. The networks meeting will focus on the outcome of the 2018 annual workshop of the 7 June and the action plan for 2018/2019.


Committee for Medicinal Products for Human Use (CHMP): 19-22 March 2018, European Medicines Agency, London, UK, From: 19-Mar-2018, To: 22-Mar-2018

The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines.


News and press releases: EMA restricts use of Keytruda and Tecentriq in bladder cancer

Data show lower survival in some patients with low levels of cancer protein PD-L1


News and press releases: New medicine for hereditary rare disease

Tegsedi addresses unmet medical need for treatment of hereditary transthyretin amyloidosis


News and press releases: Towards improved safety monitoring of veterinary medicines

Companies are encouraged to report all suspected side effects in EudraVigilance Veterinary


News and press releases: Highlights of 100th Management Board meeting: June 2018

Positive assessment of 2017 operations - Seat Agreement with the Netherlands signed


Committee for Medicinal Products for Human Use (CHMP): 23-26 April 2018, European Medicines Agency, London, UK, From: 23-Apr-2018, To: 26-Apr-2018

The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines.


Committee for Herbal Medicinal Products (HMPC): 4-5 June 2018, European Medicines Agency, London, UK, From: 04-Jun-2018, To: 05-Jun-2018

The Committee on Herbal Medicinal Products (HMPC) is the committee that is responsible for preparing the Agency’s opinions on questions relating to herbal medicines.


Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018, European Medicines Agency, London, UK, From: 11-Jun-2018, To: 14-Jun-2018

The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.


Management Board meeting: 6-7 June 2018, European Medicines Agency, London, UK, From: 06-Jun-2018, To: 07-Jun-2018

The Management Board is an integral governance body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency’s performance.


eXtended EudraVigilance medicinal product dictionary face-to-face training course, European Medicines Agency, London, UK, From: 20-Sep-2018, To: 21-Sep-2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.


eXtended EudraVigilance medicinal product dictionary face-to-face training course, European Medicines Agency, London, UK, From: 15-Nov-2018, To: 16-Nov-2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.


News and press releases: IT systems unavailable from 15 to 18 June 2018

EMA website and online applications will be temporarily unavailable


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Amsterdam, The Netherlands, BCN Amsterdam Arena, Amsterdam, The Netherlands, From: 10-Dec-2018, To: 12-Dec-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Vienna, Austria, AGES - Vienna, Austria, From: 01-Oct-2018, To: 02-Oct-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, San Marino, Republic of San Marino, Grand Hotel San Marino, Republic of San Marino, From: 07-Nov-2018, To: 09-Nov-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Paris, France, Châteauform’ College, Paris, France, From: 19-Nov-2018, To: 21-Nov-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Berlin, Germany, one-by-one EDV-GmbH, Berlin, Germany, From: 24-Sep-2018, To: 26-Sep-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Madrid, Spain, MSL Formacion, Madrid, Spain, From: 15-Oct-2018, To: 18-Oct-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.


The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 05-Dec-2018, To: 07-Dec-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 12-Nov-2018, To: 14-Nov-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 08-Oct-2018, To: 10-Oct-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, European Medicines Agency, London, UK, From: 17-Sep-2018, To: 19-Sep-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.


News and press releases: Reinforced EU/US collaboration on medicines

Update on the European Commission/EMA–FDA bilateral of 18-19 June 2018


News and press releases: First stem cell-based veterinary medicine recommended for marketing authorisation

Arti-Cell Forte is indicated in horses with mild to moderate lameness due to joint inflammation


News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19–21 June 2018

First stem cell-based veterinary medicine recommended for marketing authorisation


Committee for Advanced Therapies (CAT): 20-22 June 2018, European Medicines Agency, London, UK, From: 20-Jun-2018, To: 22-Jun-2018

The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.


News and press releases: Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients

Medicines to remain on the market provided that training, controlled access and warnings on the packaging are implemented


News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 June 2018

Nine medicines recommended for approval, including the first two CAR-T cell therapies in the EU


15th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting, Amsterdam, The Netherlands, From: 05-Jul-2018, To: 05-Jul-2018

European Medicines Agency (EMA) and European network for Health Technology Assessment (EUnetHTA) have been holding regular dialogue since 2010. The key topics of this meeting, which will be held in Amsterdam, are opportunities for collaboration on advanced therapy medicinal products (ATMPs), exchange on labelling principles, update on a study comparing the concepts related to orphan medicines (significant benefit vs relative effectiveness) as well as collaboration in the space of patient registries. A report from the meeting will be published in due course.


Workshop on the reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development , European Medicines Agency, London, UK, From: 03-May-2018, To: 04-May-2018

The European Medicines Agency has published a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (EMA/CHMP/138502/2017), for a 1-year public consultation until 31 March 2018. In order to facilitate multidisciplinary interaction between regulators and stakeholders on statistical methodology applied to the quality of medicines, a 1.5-day workshop is held. The main focus of the workshop is the discussion of comments received during the public consultation. Stakeholders are therefore encouraged to provide comments well in advance (ideally by the end of November 2017). Stakeholders can express their interest to participate in this workshop by writing to RP-stats-QA@ema.europa.eu. Due to limited spaces, priority will be given to those who provided relevant comments. The output of the workshop will have a direct impact on the finalisation of the reflection paper.


Using Organisations Management Service (OMS) data in electronic application forms (eAF), European Medicines Agency, London, UK, From: 27-Jun-2018, To: 27-Jun-2018

The European Medicines Agency (EMA) held a webinar with stakeholders from industry and national compentent authorities. The objective of the event was to provide an overview of Organisations Management Service (OMS) data services, outline the impacts of intergation of OMS with the electronic application forms (eAF) and Common European Single Submission Portal (CESSP). The session also covered OMS change request process and data quality aspects.


News and press releases: EMA identifies gaps in industry preparedness for Brexit

Survey indicates that some companies need to step up efforts to ensure medicine supply in the EU


News and press releases: EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) elects new Chair

Sabine Straus from the Netherlands to begin three-year mandate from 3 September 2018


News and press releases: EMA’s proactive publication of clinical data a success

First report on unprecedented transparency policy shows high user satisfaction


Follow up information session on the TransCelerate initiative, European Medicines Agency, London, UK, From: 17-Jul-2018, To: 17-Jul-2018

The meeting provides an opportunity for TransCelerate to update the European Medicines Agency on progress with ongoing initiatives and new areas of work, which focuses on the development of practical solutions to overcome inefficiencies in clinical trials.


News and press releases: EU and Japan reinforce their collaboration on inspections of medicine manufacturers

Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vaccines


Committee for Advanced Therapies (CAT) expert meeting on scientific and regulatory considerations for adeno-associated viral vector (AVV)-based gene therapy, European Medicines Agency, London, UK, From: 06-Sep-2017, To: 06-Sep-2017

An increasing number of recombinant AAV-based gene therapy medicinal products have entered clinical development in various therapeutic areas, including ophthalmology, neurology, haematology, metabolic disorders and muscular disorders. During this expert meeting, the CAT discussed with invited experts various scientific aspects of recombinant AAVs such as clinical grade manufacturing, virus-host interactions in animals and humans, immunity, persistence, toxicity and clinical development.


Expert meeting on genome editing technologies used in medicine development, European Medicines Agency, London, UK, From: 18-Oct-2017, To: 18-Oct-2017

Genome editing technologies are progressing with an unprecedented speed. Medicinal products developed using these novel technologies may potentially ameliorate or cure genetic diseases. However, they also come with complexities and challenges during their development, manufacture, evaluation and ultimately making them available to patients. This meeting brings together leading academic institutions as well as industry stakeholders with the most advanced development programmes using genome editing to discuss the current state of art, challenges and opportunities linked with genome editing and to present case studies of the most advanced developments.


News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17–19 July 2018

CVMP adopts revised guidance on assessment of the risk to public health from resistance due to use of antimicrobials in food-producing animals


Paediatric Committee (PDCO): 24-27 July 2018, European Medicines Agency, London, UK, From: 24-Jul-2018, To: 27-Jul-2018

The Paediatric Committee (PDCO) is the committee that is responsible for assessing the content of paediatric investigation plans, which describe how a medicine should be studied in children, as well as waivers and deferrals.


News and press releases: IT systems unavailable from 27 to 30 July 2018

EMA website and online applications will be temporarily unavailable


News and press releases: EMA restricts use of prostate cancer medicine Xofigo

Medicine to be used only after two previous treatments or when other treatments cannot be taken


News and press releases: New medicine for hereditary rare disease

Onpattro addresses unmet medical need for treatment of hereditary transthyretin amyloidosis


Workshop with stakeholders on support to quality development in early access approaches (i.e. PRIME, Breakthrough Therapies), European Medicines Agency, London, UK, From: 26-Nov-2018, To: 26-Nov-2018

EMA and US FDA launched PRIME and Breakthrough Therapy schemes to strengthen their support to the development of medicines for unmet medical needs to help patients to benefit from these therapies as early as possible. The aim of this workshop is to discuss between Regulators and Industry technical quality challenges and scientific and regulatory approaches that could be used to facilitate development and preparation of robust CMC data packages, enabling timely access to medicines whilst providing assurance that patient safety and product quality are not compromised. Specific industry case studies (covering chemicals, biologicals and ATMPs) and experiences to date across different regions will be discussed. The workshop conclusions will be captured in a report. Development of further follow-up guidance may be considered. People interested in participating are invited to register by 31 October 2018. Due to limited space EMA will allocate places on specific criteria (see draft Agenda).


News and press releases: Brexit preparedness: EMA to further temporarily scale back and suspend activities

Next phase of business continuity plan aimed at securing essential public and animal health activities


News and press releases: Update on review of recalled valsartan medicines

Preliminary assessment of possible risk to patients


News and press releases: EMA: working for every patient in Europe

A short video to explain who EMA is and what it does


News and press releases: Update on review of valsartan medicines due to detection of NDMA

EMA reviewing valsartan produced by another company Zhejiang Tianyu


News and press releases: How are new medicines approved by EMA?

Find out what it takes to develop a medicine and to get it authorised


Committee for Orphan Medicinal Products (COMP): 19-21 June 2018, European Medicines Agency, London, UK, From: 19-Jun-2018, To: 21-Jun-2018

The Committee for Orphan Medicinal Products (COMP) is the committee that is responsible for reviewing applications for 'orphan medicinal product designation' for medicines intended for the diagnosis, prevention or treatment of rare diseases.


Committee for Medicinal Products for Veterinary Use (CVMP): 17-19 July 2018, European Medicines Agency, London, UK, From: 17-Jul-2018, To: 19-Jul-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.


News and press releases: Update on medicines containing valsartan from Zhejiang Tianyu

Company no longer authorised to manufacture valsartan active substance for EU medicines due to presence of NDMA


News and press releases: Keeping medicines safe

How EMA monitors medicines once they are on the market


News and press releases: European Medicines Agency closed 27 August 2018

EMA closed from 18:30 on Friday 24 August until 7:30 on Tuesday 28 August 2018


The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Lisbon, Portugal, Lisbon, Portugal, From: 26-Nov-2018, To: 28-Nov-2018

This hands-on training course covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.


News and press releases: Fostering medicines for children

At a glance: EMA’s support of paediatric research


News and press releases: Towards improving the availability of medicines in the EU

EU-wide task force publishes work programme 2019/20 and prepares multi-stakeholder workshop


News and press releases: Development of medicines for rare diseases

An overview of the EU’s orphan designation programme


Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety specification for biologicals with a special focus on biosimilars, so that only risks that are important for risk management and relevant for the benefit-risk of the product are included in the RMP. The Agency will provide updates on risk management aspects of the new good pharmacovigilance practice (GVP) guidance on special populations such as children and elderly. Other topics will include risk communication and patients’ access to information on the safety of medicines.


Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018, European Medicines Agency, London, UK, From: 11-Sep-2018, To: 13-Sep-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.


Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisation applicants on the data requirements and methodology to be used for assessing the risk to public health from antimicrobial resistance from use of those products in food-producing animals.


Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental approaches for dose optimisation and evaluating the consequences on withdrawal periods, target animal safety, and environmental risk assessment, with the objective of improving the SPC of veterinary antibiotics authorised in the European Union.


News and press releases: Improving understanding of biosimilars in the EU

New information material made available in several European languages


News and press releases: Committee for Orphan Medicinal Products (COMP) elects new chair

Violeta Stoyanova-Beninska to begin three-year mandate at October meeting


News and press releases: Update on review of valsartan medicines

Risk from NDMA remains low, a related substance NDEA also being investigated


European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regulatory requirements for the development of medicines for the treatment of these diseases.


News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 September 2018

CVMP invites comments on a reflection paper dealing with resistance development of certain antimicrobials and its impact on human and animal health


European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.


European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep-2018

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised medicines.


European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep-2018

This Patients' and Consumers' Working Party (PCWP) plenary meeting will include discussions on patient engagement along the regulatory lifecycle and visibility of patient input throughout scientific procedures. Feedback will also be given from the representatives of the Scientific Committees.


12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.


News and press releases: New medicine for the prevention of migraine

Monoclonal antibody Emgality recommended for marketing authorisation


News and press releases: New medicine to treat infections in adults

Vabomere, a combination of an antibiotic and new beta-lactamase inhibitor, addresses bacterial resistance


News and press releases: New gene therapy for rare inherited disorder causing vision loss recommended for approval

Luxturna is the first treatment option for hereditary retinal dystrophy with mutations of the RPE65 gene


News and press releases: EMA to launch new corporate website on 27 September 2018

Fresh design and improved features to provide better user experience


News and press releases: Companies stepping up efforts to ensure medicine supply post Brexit

Focus is now on 39 centrally authorised medicines, down from 108


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 September 2018, , 07/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>At its monthly meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) did not start or conclude a new referral. More information on all safety reviews currently under evaluation is provided in the table below.</p> <p><b>PRAC elects new vice-chair</b></p> <p>The Committee elected Dr Martin Huber from Germany as the new vice-chair to take over from Dr Álmath Spooner. Dr Spooner has served for two three-year mandates, the maximum allowed by the legislation. EMA would like to thank Dr Spooner for the dedication and knowledge that she put at service to ensure the safety of medicines in the European Union. Dr Huber is Head of the unit 'PRAC, Legal Status, Adverse Reaction Reports, Medication Errors' at the BfArM (Federal Institute for Drugs and Medical Devices), in Germany. He has been a member of the PRAC since its inception in 2012.</p> <p>This month, the PRAC also focused on the broad range of its responsibilities which cover all aspects of the risk management of the use of medicines. Information on all topics discussed by the PRAC is available below in the agenda for the meeting. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting at the beginning of October.</p> <h3><b>Agenda</b></h3> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th valign="top"> </th> </tr></thead><tbody><tr><td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/agenda/agenda-prac-draft-agenda-meeting-3-6-september-2018_en.pdf" target="_blank" type="application/pdf; length=644017">Agenda - PRAC draft agenda of meeting 3-6 September 2018</a> </span> </td> </tr></tbody></table><p> </p> <h3>Ongoing referrals</h3> <table border="1" cellpadding="0" cellspacing="0"><thead><tr><th style="width:262px" valign="top"><strong>Procedure</strong></th> <th style="width:92px" valign="top"><strong>Status</strong></th> <th style="width:615px" valign="top"><strong>Update</strong></th> </tr></thead><tbody><tr><td style="width:262px" valign="top"><a href="/en/medicines/human/referrals/quinolone-fluoroquinolone-containing-medicinal-products">Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal products</a></td> <td style="width:138px" valign="top">Under evaluation</td> <td valign="top">PRAC continues its assessment</td> </tr><tr><td style="width:262px" valign="top"><a href="/en/medicines/human/referrals/methotrexate-containing-medicinal-products">Article-31 procedure: Methotrexate containing medicinal products</a></td> <td style="width:138px" valign="top">Under evaluation</td> <td valign="top">PRAC continues its assessment</td> </tr></tbody></table><p> </p> </div> </div> </div>


Towards improving the availability of medicines in the EU, , 29/08/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The <a href="http://www.hma.eu/522.html">task force</a> set up by European Union (EU) regulators to better address potential problems with medicines' supply and to avoid <a href="/en/human-regulatory/post-authorisation/medicine-shortages">shortages</a> published today its <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/work-programme/work-programme-hma/ema-task-force-availability-authorised-medicines-human-veterinary-use_en.pdf" target="_blank" type="application/pdf; length=91572">work programme for the coming two years</a> </span> . Improving the availability of human and veterinary medicines authorised in the EU is a key <a href="/en/about-us/how-we-work/european-medicines-regulatory-network/eu-medicines-agencies-network-strategy-2020">priority of the EU Network</a>. The work programme lists actions for regulators and industry alike to ensure the availability of medicines for the benefit of patients in the EU.</p> <p>The task force has been set up by the European Medicines Agency (EMA) and the <a href="/en/partners-networks/eu-partners/eu-member-states/heads-medicines-agencies">Heads of Medicines Agencies (HMA)</a>, with representatives from the European Commission and interested national competent authorities, the chairs of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and Veterinary (CMDv), the GMP/GDP Inspectors Working Group, the Working Group of Communication Professionals (WGCP) and the European Surveillance Strategy Working Group (ESS WG).</p> <p>The task force will develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect the availability of medicines, in order to improve continuity of supply of human and veterinary medicines across Europe.</p> <p>Key priorities of the task force include:</p> <ul><li>looking at ways to minimise supply disruptions and avoid shortages by facilitating approval and marketing of medicines using the existing regulatory framework (e.g. using work sharing and reduced timetables when possible);</li> <li>developing strategies to improve prevention and management of shortages caused by disruptions in the supply chain (e.g. developing guidance for companies on reporting of shortages);</li> <li>encouraging best practices within industry to prevent shortages;</li> <li>improving sharing of information and best practices among EU regulatory authorities to better coordinate actions across the EU;</li> <li>fostering collaboration with stakeholders and enhancing communication of supply problems to EU citizens.</li> </ul><p>The task force will organise a multi-stakeholder workshop on 8-9 November 2018 to gather stakeholders' perspectives on how to address availability issues and to include their input into the deliverables of the task force. It will bring together all stakeholders impacted, including patients, consumers, healthcare professionals, industry, wholesalers/distributors, parallel distributors, academia and regulators.</p> <p>The <a href="/en/about-us/united-kingdoms-withdrawal-european-union-brexit">withdrawal of the United Kingdom from the EU</a> is also likely to affect the availability of medicines in the EU. In this context, the task force provides a platform to facilitate and coordinate actions between Member States, EMA and the European Commission.</p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/towards-improving-availability-medicines-eu_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Towards improving the availability of medicines in the EU <small class="ema-u-color-grey-2"> (PDF/115.24 KB) </small> <small class="ema-u-color-epar-red"> (updated)</small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 29/08/2018 <br/> Last updated: 29/08/2018 <br/> EMA/485874/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Development of medicines for rare diseases, , 31/08/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>A disease is considered rare if fewer than five in 10,000 people have it. Around 30 million people in the European Union (EU) suffer from a debilitating rare disease, which means one in 17 people. Finding effective treatment for these rare diseases is a huge challenge.</p> <p>In 2000, the EU's <a href="/en/human-regulatory/overview/orphan-designation">orphan designation</a> programme was launched to encourage companies to research and develop medicines for rare diseases. By the end of 2017, over 1,900 medicines had been granted orphan status that gives access to specific incentives that make it more attractive for companies to develop these treatments. To date, over 140 orphan medicines are marketed in the EU providing new treatment options for patients.</p> <p>To find out more about the EU programme and the incentives available to developers, check out our <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/leaflet/leaflet-orphan-medicines-eu_en.pdf" target="_blank" type="application/pdf; length=1069945">infographic</a> </span> .</p> </div> </div> </div>


Committee for Orphan Medicinal Products (COMP) elects new chair, , 13/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p><img alt="Dr Stoyanova-Beninska" src="/sites/default/files/AA_portrait_Violeta_Stoyanova-Beninskas.jpg" style="float:left; margin-left:15px; margin-right:15px" /><span style="font-size:14.634px">The European Medicines Agency's (EMA) </span><a href="/en/committes/committee-orphan-medicinal-products-comp" style="font-size:14.634px; background-color:rgb(255, 255, 255)">Committee for Orphan Medicinal Products</a><span style="font-size:14.634px"> (COMP) has elected Dr Violeta Stoyanova-Beninska as its new chair for a three-year mandate. She follows Professor Bruno Sepodes who served as COMP chair for two three-year terms, the maximum number allowed.</span></p> <p>Dr Stoyanova-Beninska has been working since 2007 at the Dutch national competent authority, the <a href="https://english.cbg-meb.nl/">Medicines Evaluation Board</a> (MEB), as a senior clinical assessor. She has strong expertise in neurology, psychiatry, and ophthalmological, dermatological and pain management.</p> <p>She has been involved in EMA activities since 2009, first in the <a href="/en/committes/working-parties-other-groups/chmp/scientific-advice-working-party">Scientific Advice Working Party</a> (SAWP) and since 2012 as a member of the COMP.</p> <p>“I cherish the unique responsibility the COMP has in the interest of patients suffering from rare diseases. Building on what has been achieved over the past 18 years since the COMP was established, I will work closely with all committee members and experts, building on the high professionalism and the collaborative spirit in the committee,” said Violeta Stoyanova-Beninska. “Orphan medicines have their specific challenges which we shall tackle involving all stakeholders. As chair, I would like to contribute to reinforcing the COMP's interaction and communication with other scientific committees at EMA and also with international partners.”</p> <p>EMA would like to thank Professor Bruno Sepodes for the dedication and knowledge that he has put at service to the COMP over the past six years.</p> <p>The COMP is responsible for evaluating applications for <a href="/en/human-regulatory/overview/orphan-designation">orphan designation</a>. This designation is for medicines to be developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. It gives access to incentives offered by the European Union to encourage companies to research and develop medicines for rare diseases that otherwise would not be developed.</p> </div> </div> </div>


Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 September 2018, , 14/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><h4>CVMP invites comments on a reflection paper dealing with resistance development of certain antimicrobials and its impact on human and animal health</h4> <p><b>CVMP opinions on veterinary medicinal products</b></p> <p>The Committee adopted by consensus<i> </i>positive opinions for the extensions of the existing marketing authorisations for <b>Inflacam </b>and<b> Rheumocan</b> (<i>meloxicam</i>), from Chanelle Pharmaceuticals Manufacturing Ltd, concerning the addition of a new pharmaceutical form (oral suspension) and strength (0.5 mg/ml) for the alleviation of mild to moderate post-operative pain and inflammation following surgical procedures, and alleviation of pain and inflammation in acute and chronic musculo‑skeletal disorders in cats.</p> <p>The Committee also adopted<b> </b>by consensus positive opinions for type II variation applications for<b> ORSURNIA</b><i>, </i><b>Porcilis PCV M Hyo</b> and<b> RESPIPORC FLUpan H1N1 </b>regarding quality changes.</p> <p>The Committee adopted by consensus a positive opinion for a type II grouped variation application for<b> ZACTRAN </b>regarding quality changes.</p> <p>The Committee adopted by consensus a positive opinion for a type II variation application for<b> Econor</b><i>, </i>concerning updates of the SPC due to new preclinical data.</p> <p>The Committee adopted by consensus a positive opinion for a type II grouped variation application (subject to a worksharing procedure) for <b>NexGard</b> and<b> NEXGARD SPECTRA</b> concerning the addition of new therapeutic indications for the treatment of demodicosis and sarcoptic mange.</p> <p>The Committee adopted by consensus a positive opinion for a type II variation application (subject to a worksharing procedure) for <b>Versican Plus DHPPI</b>,<b> Versican Plus DHPPi/L4</b>,<b> Versican Plus DHPPi/L4R</b>, <b>Versican Plus L4</b>,<b> Versican Plus Pi</b>, <b>Versican Plus Pi/L4 </b>and<b> Versican Plus Pi/L4R</b> concerning the introduction of changes in the product information regarding use during pregnancy.</p> <p>The Committee adopted by consensus<b> </b>positive opinions for type II variation applications (subject to a worksharing procedure), concerning quality changes, for:</p> <p><b>- Versican Plus DHPPi </b>and <b>Versican Plus Pi</b>;</p> <p><b>- Versican Plus DHPPi/L4R, Versican Plus DHPPi/L4, Versican Plus L4, Versican Plus Pi/L4R </b>and<b> Versican Plus Pi/L4</b>;</p> <p><b>- Versican Plus DHPPi, Versican Plus Pi, Versican Plus Pi/L4, Versican Plus DHPPi/L4, Versican Plus DHPPi/L4R </b>and<b> Versican Plus Pi/L4R</b>; and</p> <p><b>- Versican Plus DHPPi, Versican Plus Pi, Versican Plus DHPPi/L4R, Versican Plus DHPPi/L4, Versican Plus Pi/L4R </b>and<b> Versican Plus Pi/L4</b>.</p> <p>More information about the above mentioned medicines, including their full indication, will be published on the Agency's website.</p> <p><b>Scientific advice</b></p> <p>The Committee adopted 2 separate scientific advice reports further to requests for:</p> <ul><li>Initial advice on safety and efficacy issues for a pharmaceutical veterinary medicinal product for cats;</li> <li>Initial advice on efficacy issues for a pharmaceutical veterinary medicinal product for dogs.</li> </ul><p><b>Minor use, minor species (MUMS)/limited market</b></p> <p>Following the Committee's review of 5 requests for classification under the MUMS/limited market policy, the CVMP:</p> <ul><li>Did not classify a product (musculo-skeletal system) for dogs as indicated for MUMS/limited market.</li> <li>Did not classify a product (immunologicals) for chickens as indicated for MUMS/limited market.</li> <li>Reclassified a product (musculo-skeletal system) for horses as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as, according to the MUMS policy, products for horses are generally not eligible for fee incentives.</li> <li>Reclassified a product (musculo-skeletal system) for horses as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as, according to the MUMS policy, products for horses are generally not eligible for fee incentives.</li> </ul><p><b>Pharmacovigilance</b></p> <p>The Committee reviewed the PSURs for <b>LETIFEND, Meloxidolor, Nobilis IB Primo QX </b>and <b>Zeleris, </b>and concluded that no further action or changes to their product information were required.</p> <p>The Committee reviewed the PSURs for <b>CYTOPOINT, Nobilis IB4-91, OSURNIA, RHINISENG </b>and the targeted PSUR for <b>Easotic</b>,<b> </b>and recommended amendments to the product literature.</p> <p><b>Concept papers, guidelines and SOPs</b></p> <p><b><i>Safety</i></b></p> <p>The Committee adopted a guideline on determination of withdrawal periods for edible tissues (EMA/CVMP/SWP/735325/2012) following the close of the public consultation. The guideline replaces and updates the previous Note for Guidance: Approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95 FINAL). In addition to providing guidance on determination of withdrawal periods the new document reports on considerations relating to alternative approaches for dealing with residue data below the limit of quantification and incorporates a number of updates to references and clarifications, as described in Annex E of the document.</p> <p>The guideline together with the overview of comments (EMA/CVMP/SWP/81095/2017) will be published on the Agency's website.</p> <p><b><i>Efficacy</i></b></p> <p>The Committee adopted a draft reflection paper on ectoparasitic resistance (EMA/CVMP/EWP/310225/2014) for an 11-month period of public consultation. The reflection paper aims to give an overview of the known resistance of ectoparasites to active substances used in veterinary medicinal products with a special focus on Europe, and to provide a review of the current knowledge on resistance mechanisms.</p> <p>The document will be published on the Agency's website.</p> <p><b><i>Antimicrobials</i></b></p> <p>The Committee adopted a draft reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union (EMA/CVMP/AWP/842786/2015) for a 3-month period of public consultation. The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.</p> <p>The document will be published on the Agency's website.</p> <p>The Committee agreed to extend the consultation period of the guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances (EMA/CVMP/383441/2005-Rev.1) until the end of August 2019 when the CVMP working party activities are expected to resume.</p> <p><b>Working parties</b></p> <p>The Committee reviewed and adopted the revised mandate (EMA/CVMP/ERA/705470/2009-Rev.5) for the CVMP Environmental Risk Assessment Working Party (ERAWP) for a further period of 3 years.</p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-september-2018_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 September 2018 <small class="ema-u-color-grey-2"> (PDF/91.98 KB) </small> <small class="ema-u-color-epar-red"> (updated)</small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 14/09/2018 <br/> Last updated: 14/09/2018 <br/> EMA/CVMP/596810/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Improving understanding of biosimilars in the EU, , 13/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency (EMA) and the <a href="https://ec.europa.eu/commission/index_en">European Commission</a> have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU). A biosimilar is biological medicine that is highly similar in all essential aspects to a 'reference' biological medicine already authorised.</p> <p>The new material includes an animated video for patients that explains key facts on biosimilar medicines and how EMA works to ensure that they are as safe and effective as their reference biological medicines. The video is available in eight European languages: <a href="https://www.youtube.com/watch?v=x4sXS9HmiBo&list=PL7K5dNgKnawb3IQri7lIr5wbaWxP71jQJ&index=3">Dutch</a>, <a href="https://www.youtube.com/watch?v=YPIvVl4xwFg&list=PL7K5dNgKnawb3IQri7lIr5wbaWxP71jQJ">English</a>, <a href="https://www.youtube.com/watch?v=70sVGNVG7Jk&list=PL7K5dNgKnawb3IQri7lIr5wbaWxP71jQJ&index=5">French</a>, <a href="https://www.youtube.com/watch?v=DgHj5O7tfFU&index=2&list=PL7K5dNgKnawb3IQri7lIr5wbaWxP71jQJ">German</a>, <a href="https://www.youtube.com/watch?v=9793RZPYCT8&index=4&list=PL7K5dNgKnawb3IQri7lIr5wbaWxP71jQJ">Italian</a>, <a href="https://www.youtube.com/watch?v=oNP-yvJ0CoU&list=PL7K5dNgKnawb3IQri7lIr5wbaWxP71jQJ&index=6">Polish</a>, <a href="https://www.youtube.com/watch?v=6uyG2lW6ogY&index=8&list=PL7K5dNgKnawb3IQri7lIr5wbaWxP71jQJ">Portuguese</a> and <a href="https://www.youtube.com/watch?v=_WX7V67xhnA&index=7&list=PL7K5dNgKnawb3IQri7lIr5wbaWxP71jQJ">Spanish</a>.</p> <p><iframe allowfullscreen="allowfullscreen" frameborder="0" height="315" src="https://www.youtube.com/embed/YPIvVl4xwFg?list=PL7K5dNgKnawb3IQri7lIr5wbaWxP71jQJ" width="533"></iframe></p> <p>The other documents published today are the translations of the <a href="http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf">biosimilar guide for healthcare professionals</a> into <a href="http://www.ema.europa.eu/docs/nl_NL/document_library/Leaflet/2017/05/WC500226648.pdf">Dutch</a>, <a href="http://www.ema.europa.eu/docs/fr_FR/document_library/Leaflet/2017/05/WC500226648.pdf">French</a>, <a href="http://www.ema.europa.eu/docs/de_DE/document_library/Leaflet/2017/05/WC500226648.pdf">German</a>, <a href="http://www.ema.europa.eu/docs/it_IT/document_library/Leaflet/2017/05/WC500226648.pdf">Italian</a>, <a href="http://www.ema.europa.eu/docs/pl_PL/document_library/Leaflet/2017/05/WC500226648.pdf">Polish</a>, <a href="http://www.ema.europa.eu/docs/pt_PT/document_library/Leaflet/2017/05/WC500226648.pdf">Portuguese</a> and <a href="http://www.ema.europa.eu/docs/es_ES/document_library/Leaflet/2017/05/WC500226648.pdf">Spanish</a>. The guide, which was first made available in English in 2017, provides <a href="/en/partners-networks/healthcare-professionals">healthcare professionals</a> with comprehensive and easily understandable information on both the science and the regulation underpinning the use of biosimilars.</p> <p>These newly published materials complement the <a href="http://ec.europa.eu/DocsRoom/documents/26643">Questions & answers on biosimilars for patients</a> in 23 EU languages previously made available by EMA and the European Commission. In addition, as for all medicines, the Agency publishes <a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&genericsKeywordSearch=Submit">a public friendly overview</a> which explains why the biosimilar medicine has been approved for use in the EU.</p> <p>Biosimilar medicines offer alternatives to patients and doctors in the EU and so increase the availability of biological treatments for patients who need them.</p> <p>The newly available materials will be presented at the <a href="https://ec.europa.eu/growth/content/fourth-stakeholder-conference-biosimilar-medicines_en">European Commission's fourth multi-stakeholder conference on biosimilar medicines</a> in Brussels on Friday, 14 September 2018. This conference aims to promote the exchange of information and expand patients' and healthcare professionals' knowledge on biosimilar medicines. The discussion will focus on three main topics: biosimilars in oncology, sustainable procurement and educational activities to improve understanding of biosimilars.</p> <p>To find out more about biosimilars visit our <a href="/en/human-regulatory/overview/biosimilar-medicines">webpage on biosimilar medicines</a>.</p> <p><b>Note</b></p> <ul><li>Due to the ongoing business continuity plan, translations into the remaining EU languages are now expected to become available in the second half of next year.</li> </ul></div> </div> </div>


Fostering medicines for children, , 28/08/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>Children react differently to medicines than adults, which is why it is important that medicines are properly studied and demonstrated to be safe and effective for minors.</p> <p>Further to the introduction of the <a href="/en/human-regulatory/overview/paediatric-medicines/paediatric-regulation">Paediatric Regulation</a> in the European Union (EU) in 2007, manufacturers are required to consider children's therapeutic needs when researching and developing medicines. This regulation also created the European Medicines Agency's (EMA) <a href="/en/committes/paediatric-committee-pdco">Paediatric Committee</a> (PDCO) that is responsible for reviewing <a href="/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans">paediatric investigation plans</a> (PIPs).</p> <p>The Paediatric Regulation has raised awareness of the need to study medicines in children, and paediatric research is now standard practice in the development of medicines.</p> <p>Between 2007 and 2017, more than 200 medicines for children were authorised. This accounts for 25% of all new medicines authorised for marketing in the EU.</p> <p>EMA also runs the <a href="/en/partners-networks/networks/european-network-paediatric-research-european-medicines-agency-enpr-ema">European Network of Paediatric Research</a> (Enpr-EMA), a network of research networks, investigators and centres with recognised expertise in clinical studies with children.</p> <p>Check out our <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/report/supporting-medicines-children-european-union_en.pdf" target="_blank" type="application/pdf; length=1616890">infographic</a> </span> .</p> </div> </div> </div>


Update on review of valsartan medicines, , 13/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency (EMA) has updated its calculation of the risk from valsartan medicines containing N‑nitrosodimethylamine (NDMA), taking into account results from latest tests on the active substance from Zhejiang Huahai.</p> <p>In line with EMA's previous assessment, the life-time risk of cancer is considered low and is estimated to be in the order of 1 in 5,000 for an adult patient who had taken an affected valsartan medicine at the highest dose (320 mg) every day from July 2012 to July 2018.</p> <p>EMA's risk assessment is based on the average levels of NDMA in the active substance produced by Zhejiang Huahai since 2012 (when the company changed its manufacturing process) and on the assumption that all the NDMA is transferred to the final product.</p> <p>Patients who have taken treatments with lower doses or for shorter lengths of time will be at a lower risk. The risk will also be lower for patients who have taken valsartan produced by Zhejiang Tianyu, which had smaller amounts of NDMA than valsartan produced by Zhejiang Huahai.</p> <p>The low risk estimate is to some extent supported by a Danish study<sup>1</sup> which tracked patients who had taken medicines containing valsartan from Zhejiang Huahai over the past 6 years. However, the authors note that patients were followed up for a relatively short period (4.6 years on average).</p> <p>In addition to NDMA, EMA is assessing the impact of a related substance, N‑nitrosodiethylamine (NDEA), which has been detected in valsartan made by Zhejiang Huahai using its previous manufacturing process before changes were introduced in 2012. Both NDEA and NDMA belong to the class of nitrosamines and are classified as probable human carcinogens (substances that could cause cancer).</p> <p>Data on levels of NDEA are currently very limited, and EMA will provide further information on whether its presence impacts the risk assessment once more information becomes available.</p> <p>Although the review covers all valsartan medicines, the immediate focus has been on medicines containing the active substance manufactured by <a href="/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity">Zhejiang Huahai</a> and <a href="/en/news/update-medicines-containing-valsartan-zhejiang-tianyu">Zhejiang Tianyu</a> where unacceptable levels of NDMA have been confirmed. EU authorities have now carried out inspections of the manufacturing sites of both companies in China and will consider the findings.</p> <p>Medicines containing valsartan from Zhejiang Huahai and Zhejiang Tianyu are no longer being distributed in the EU or have been recalled. Both companies are not currently authorised to produce valsartan for medicines in the EU.</p> <p>EMA continues to work closely with national authorities, international partners and EDQM to gather the necessary information which would allow the Agency to have a better understanding of why impurities were present in the active substance in the first place.</p> <p>Based on the final outcome of the review, authorities in the EU will take necessary measures to ensure that similar problems do not occur in future.</p> <hr /><p><b>More about the medicine</b></p> <p>Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own or in combination with other active substances.</p> <p>Medicines containing valsartan as the only active substance have been authorised in the EU via national authorities. <a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByKey&alreadyLoaded=true&isNewQuery=true&status=Authorised&keyword=valsartan&searchType=inn&taxonomyPath=&treeNumber=&searchGenericType=generics">Nine products</a> containing valsartan in combination with other active substances have been authorised centrally via EMA.</p> <p><b>More about the procedure</b></p> <p>The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under <a href="/en/human-regulatory/post-authorisation/referral-procedures">Article 31 of Directive 2001/83/EC</a>.</p> <p>The review is being carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency's opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.</p> <hr /><p><sup>1</sup> Pottegard A, Kristensen K, Ernst MT, Johansen NB, Quartorolo P, Hallas J. Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study. <a href="https://www.bmj.com/content/362/bmj.k3851?ijkey=ec3a867343b40c9dc6f4fd1f37cc4637b576c5e2&keytype2=tf_ipsecsha">BMJ 2018;362:k3851</a></p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/update-review-valsartan-medicines_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Update on review of valsartan medicines <small class="ema-u-color-grey-2"> (PDF/70.49 KB) </small> <small class="ema-u-color-epar-red"> (updated)</small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 13/09/2018 <br/> Last updated: 13/09/2018 <br/> EMA/585263/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018, , 21/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) <a href="https://www.ema.europa.eu/en/news/emas-committee-medicinal-products-human-use-chmp-elects-new-chair">elected Harald Enzmann as its new chair</a> at its September 2018 meeting, for a three-year mandate starting on 21 September.</p> <p>This week's meeting of the CHMP was the last plenary meeting chaired by Dr Tomas Salmonson, who retires as chair after serving for two three-year mandates, the maximum allowed by the legislation. Dr Salmonson is a senior scientific advisor at the Swedish Medical Products Agency, where he has worked since 1986. He has been a member of the CHMP for more than 18 years and has served as chair of the Committee since September 2012.</p> <p>EMA would like to thank Dr Salmonson for his outstanding contribution to the work of the CHMP, which has enabled progress in key areas of public health. In 2016, he was closely involved in the launch of the PRIority MEdicines scheme (PRIME), which supports the development of promising new medicines in the European Union (EU). Under his leadership, the Committee improved its benefit-risk methodologies considering new scientific developments and technological advances and it broke new ground in its engagement with key stakeholders, such as international regulators, health technology assessment bodies and patients, who have started to participate in the Committee's decision-making on medicines. Over the six years at the helm of the CHMP, he has promoted EMA and the EU regulatory system as a whole as a hub of excellence for medicines regulation for the benefit of public health in the EU and around the world.</p> <p><b>Thirteen medicines recommended for approval, including three orphans</b></p> <p>The CHMP recommended thirteen medicines for approval, including three orphan medicines<sup>1</sup>.</p> <p>The Committee recommended granting a marketing authorisation for the gene therapy <b>Luxturna</b> (voretigene neparvovec), for the treatment of adults and children with inherited retinal dystrophy caused by RPE65 gene mutations, a rare genetic disorder which causes vision loss and usually leads to blindness. Luxturna was designated as an orphan medicine during its development. For more information, please see the press release in the grid below.</p> <p>The CHMP recommended granting a marketing authorisation for <b>Emgality</b> (galcanezumab), a monoclonal antibody for the prevention of migraine. Emgality belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks. For more information, please see the press release in the grid below.</p> <p>The CHMP recommended granting a marketing authorisation for a new antibiotic, <b>Vabomere</b> (meropenem trihydrate / vaborbactam), for the treatment of various severe infections in adults. The development of new and effective antibiotics is one of the most powerful tools to fight antimicrobial resistance. For more information, please see the press release in the grid below.</p> <p>Two more orphan medicines received a positive opinion from the Committee: <b>Jivi </b>(damoctocog alfa pegol), for the treatment of haemophilia A (congenital factor VIII deficiency), and <b>Poteligeo</b> (mogamulizumab), for the treatment of mycosis fungoides or Sézary syndrome.</p> <p>The CHMP recommended granting marketing authorisations for two cancer medicines: <b>Alunbrig</b> (brigatinib), for the treatment of anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, and <b>Apealea</b> (paclitaxel), for the treatment of ovarian cancer.</p> <p><b>Delstrigo</b> (doravirine / lamivudine / tenofovir disoproxil) and <b>Pifeltro</b> (doravirine) received positive opinions for the treatment of HIV-1 infection.</p> <p>Three biosimilar medicines intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy received a positive opinion from the Committee: <b>Fulphila</b> (pegfilgrastim), <b>Pelmeg</b> (pegfilgrastim) and <b>Ziextenzo</b> (pegfilgrastim).</p> <p>The CHMP granted a positive opinion for <b>Buvidal</b> (buprenorphine), a hybrid medicine for the treatment of opioid dependence. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of a reference product and in part on new data.</p> <p><b>Negative recommendation on a new medicine following re-examination</b></p> <p>The applicant for <b>Exondys</b> (eteplirsen) requested a re-examination of the Committee's negative opinion for this medicine adopted at the May 2018 meeting. After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed its previous recommendation to refuse the granting of a marketing authorisation for this medicine.</p> <p>For more information on this negative opinion, please see the question-and-answer document in the grid below.</p> <p><b>Seven recommendations on extensions of therapeutic indication</b></p> <p>The applicants for <b>Blincyto</b> (blinatumomab), <b>Opdivo</b> (nivolumab) and <b>Yervoy</b> (ipilimumab) have requested re-examination of the Committee's negative opinions for these medicines adopted at the July 2018 meeting. The CHMP will now re-examine the opinions and issue final recommendations.</p> <p>For more information on these negative opinions, please see the question-and-answer documents in the grid below.</p> <p><b>Update on valsartan review</b></p> <p>The CHMP is expanding its <a href="/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity">review</a> of impurities in valsartan following the detection of very low levels of N-nitrosodiethylamine (NDEA) in another active substance, losartan, made by Hetero Labs in India. As a result of the detection of this impurity by German authorities, the review will now include medicines containing four other 'sartans', namely, candesartan, irbesartan, losartan and olmesartan. For more information, please see the public health communication in the grid below.</p> <p><b>Withdrawals of applications</b></p> <p>Applications for initial marketing authorisations for <strong>Entolimod TMC</strong> (entolimod) and <strong>Treprostinil SciPharm Sàrl</strong> (treprostinil) have been withdrawn. Entolimod TMC was intended to be used to reduce the risk of death following exposure to potentially lethal amounts of radiation. Treprostinil SciPharm Sàrl was intended to be used to treat chronic thromboembolic pulmonary hypertension.</p> <p>Questions-and-answers documents on these withdrawals are available in the grid below.</p> <p><b>Agenda and minutes</b></p> <p>The agenda of the September 2018 meeting is published on EMA's website. Minutes of the July 2018 CHMP meeting will be published in the coming weeks.</p> <p><b>CHMP statistics</b></p> <p>Key figures from the September 2018 CHMP meeting are represented in the graphic below.</p> <hr /><p><sup>1</sup> As always at time of approval, these orphan designations will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicines' orphan status and granting the medicines ten years of market exclusivity.</p> <p><a href="/documents/document_library/Report/2018/09/WC500255745.pdf"><img alt="" src="/sites/default/files/CHMP_highlights_September_2018.png" /></a></p> <p> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/report/chmp-statistics-september-2018_en.pdf" target="_blank" type="application/pdf; length=770859">Download image in pdf format</a> </span> </p> <p> </p> <h3>Positive recommendations on new medicines</h3> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:24px" width="35%"><strong>Name of medicine</strong></th> <th style="height:24px">Alunbrig</th> </tr></thead><tbody><tr><td style="height:26px" width="35%">International non-proprietary name (INN)</td> <td style="height:26px">brigatinib</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Takeda Pharma A/S</td> </tr><tr><td style="height:48px" width="35%">Therapeutic indication</td> <td style="height:49px">Treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer previously treated with crizotinib</td> </tr><tr><td style="height:19px">More information</td> <td style="height:19px"> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-alunbrig_en.pdf" target="_blank" type="application/pdf; length=72589">Summary of opinion for Alunbrig </a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Apealea</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">paclitaxel</td> </tr><tr><td style="height:22px" width="35%">Marketing-authorisation applicant</td> <td style="height:22px">Oasmia Pharmaceutical AB</td> </tr><tr><td style="height:28px" width="35%">Therapeutic indication</td> <td style="height:28px">Treatment of ovarian cancer</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-apealea_en.pdf" target="_blank" type="application/pdf; length=69039">Summary of opinion for Apealea</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Delstrigo</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">doravirine / lamivudine / tenofovir disoproxil</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Merck Sharp & Dohme B.V.</td> </tr><tr><td width="35%">Therapeutic indication</td> <td>Treatment of HIV-1 infection</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-delstrigo_en.pdf" target="_blank" type="application/pdf; length=70195">Summary of opinion for Delstrigo</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Emgality</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">galcanezumab</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Eli Lilly Nederland B.V.</td> </tr><tr><td width="35%">Therapeutic indication</td> <td>Prophylaxis of migraine</td> </tr><tr><td>More information</td> <td> <p> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/summary-opinion-emgality_en.pdf" target="_blank" type="application/pdf; length=108271">Summary of opinion for Emgality</a> </span> </p> <p> </p> <p>Press release: <a href="/pages/news_and_events/news/2018/09/news_detail_003024.xml">New medicine for the prevention of migraine</a></p> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Jivi</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">damoctocog alfa pegol</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Bayer AG</td> </tr><tr><td width="35%">Therapeutic indication</td> <td>Treatment of haemophilia A (congenital factor VIII deficiency)</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-jivi_en.pdf" target="_blank" type="application/pdf; length=120431">Summary of opinion for Jivi</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Luxturna</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">voretigene neparvovec</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Spark Therapeutics Ireland Ltd</td> </tr><tr><td width="35%">Therapeutic indication</td> <td>Treatment of retinal dystrophies caused by RPE65 mutations</td> </tr><tr><td>More information</td> <td> <p> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-luxturna_en.pdf" target="_blank" type="application/pdf; length=70359">Summary of opinion for Luxturna</a> </span> </p> <p> </p> <p>Press release: <a href="/pages/news_and_events/news/2018/09/news_detail_003025.xml">New gene therapy for rare inherited disorder causing vision loss recommended for approval</a></p> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Pifeltro</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">doravirine</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Merck Sharp & Dohme B.V.</td> </tr><tr><td width="35%">Therapeutic indication</td> <td>Treatment of HIV-1 infection</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-pifeltro_en.pdf" target="_blank" type="application/pdf; length=69923">Summary of opinion for Pifeltro</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Poteligeo</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">mogamulizumab</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Kyowa Kirin Limited</td> </tr><tr><td width="35%">Therapeutic indication</td> <td>Treatment of mycosis fungoides or Sézary syndrome</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-poteligeo_en.pdf" target="_blank" type="application/pdf; length=71427">Summary of opinion for Poteligeo</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Vabomere</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">meropenem / vaborbactam</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Rempex London Ltd</td> </tr><tr><td width="35%">Therapeutic indication</td> <td> <p>Vabomere is indicated for the treatment of the following infections in adults:</p> <ul><li>Complicated urinary tract infection (cUTI), including pyelonephritis</li> <li>Complicated intra-abdominal infection (cIAI)</li> <li>Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).</li> </ul><p>Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Vabomere is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.</p> </td> </tr><tr><td style="height:77px">More information</td> <td style="height:78px"> <p> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/summary-opinion-vabomere_en.pdf" target="_blank" type="application/pdf; length=79295">Summary of opinion for Vabomere</a> </span> </p> <p> </p> <p>Press release: <a href="/pages/news_and_events/news/2018/09/news_detail_003026.xml">New medicine to treat infections in adults</a></p> </td> </tr></tbody></table><p> </p> <h3>Positive recommendations on new biosimilar medicines</h3> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Fulphila</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">pegfilgrastim</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>MYLAN S.A.S</td> </tr><tr><td width="35%">Therapeutic indication</td> <td>To reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-fulphila_en.pdf" target="_blank" type="application/pdf; length=70430">Summary of opinion for Fulphila</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Pelmeg</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">pegfilgrastim</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Cinfa Biotech S.L.</td> </tr><tr><td width="35%">Therapeutic indication</td> <td>To reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-pelmeg_en.pdf" target="_blank" type="application/pdf; length=70271">Summary of opinion for Pelmeg</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Ziextenzo</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">pegfilgrastim</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Sandoz GmbH</td> </tr><tr><td width="35%">Therapeutic indication</td> <td>To reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-ziextenzo_en.pdf" target="_blank" type="application/pdf; length=70794">Summary of opinion for Ziextenzo</a> </span> </td> </tr></tbody></table><p> </p> <h3>Positive recommendation on new <b>hybrid medicine</b></h3> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Buvidal</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">buprenorphine</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Camurus AB</td> </tr><tr><td width="35%">Therapeutic indication</td> <td>Treatment of opioid dependence</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop-initial/summary-opinion-buvidal_en.pdf" target="_blank" type="application/pdf; length=70366">Summary of opinion for Buvidal</a> </span> </td> </tr></tbody></table><p> </p> <h3>Negative recommendation for new medicine following re-examination</h3> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Exondys</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">eteplirsen</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>AVI Biopharma International Ltd.</td> </tr><tr><td width="35%">Therapeutic indication</td> <td>Treatment of Duchenne muscular dystrophy</td> </tr><tr><td>More information</td> <td><a class="pdf" href="/documents/document_library/Summary_of_opinion_-_Initial_authorisation/human/004355/WC500249920.pdf">Questions and answers on Exondys</a></td> </tr></tbody></table><p> </p> <h3>Positive recommendations on extensions of therapeutic indications</h3> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th width="35%">Name of medicine</th> <th>Cabometyx</th> </tr></thead><tbody><tr><td width="35%">INN</td> <td>cabozantinib</td> </tr><tr><td width="35%">Marketing-authorisation holder</td> <td>Ipsen Pharma</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-cabometyx_en.pdf" target="_blank" type="application/pdf; length=70651">Summary of opinion for Cabometyx</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th width="35%">Name of medicine</th> <th>Elebrato Ellipta</th> </tr></thead><tbody><tr><td width="35%">INN</td> <td>fluticasone furoate / umeclidinium / vilanterol fluticasone</td> </tr><tr><td width="35%">Marketing-authorisation holder</td> <td>GlaxoSmithKline Trading Services Limited</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-elebrato-ellipta_en.pdf" target="_blank" type="application/pdf; length=71165">Summary of opinion for Elebrato Ellipta</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th width="35%">Name of medicine</th> <th>Gilenya</th> </tr></thead><tbody><tr><td width="35%">INN</td> <td>fingolimod</td> </tr><tr><td width="35%">Marketing-authorisation holder</td> <td>Novartis Europharm Limited</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-gilenya-x/44/g_en.pdf" target="_blank" type="application/pdf; length=74374">Summary of opinion for Gilenya</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th width="35%">Name of medicine</th> <th>RoActemra</th> </tr></thead><tbody><tr><td width="35%">INN</td> <td>tocilizumab</td> </tr><tr><td width="35%">Marketing-authorisation holder</td> <td>Roche Registration GmbH</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-roactemra-ii-76_en.pdf" target="_blank" type="application/pdf; length=79219">Summary of opinion for RoActemra</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th width="35%">Name of medicine</th> <th>Trelegy Ellipta</th> </tr></thead><tbody><tr><td width="35%">INN</td> <td>fluticasone furoate / umeclidinium / vilanterol fluticasone</td> </tr><tr><td width="35%">Marketing-authorisation holder</td> <td>GlaxoSmithKline Trading Services Limited</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-trelegy-ellipta_en.pdf" target="_blank" type="application/pdf; length=70119">Summary of opinion for Trelegy Ellipta</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th width="35%">Name of medicine</th> <th>Venclyxto</th> </tr></thead><tbody><tr><td width="35%">INN</td> <td>venetoclax</td> </tr><tr><td width="35%">Marketing-authorisation holder</td> <td>AbbVie Deutschland GmbH & Co. KG</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop/chmp-summary-positive-opinion-venclyxto-ii/08_en.pdf" target="_blank" type="application/pdf; length=74405">Summary of opinion for Venclyxto</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th width="35%">Name of medicine</th> <th>Xtandi</th> </tr></thead><tbody><tr><td width="35%">INN</td> <td>enzalutamide</td> </tr><tr><td width="35%">Marketing-authorisation holder</td> <td>Astellas Pharma Europe B.V.</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-xtandi-ii-39-g_en.pdf" target="_blank" type="application/pdf; length=82241">Summary of opinion for Xtandi</a> </span> </td> </tr></tbody></table><p> </p> <h3><strong>Start of </strong>re-examination<strong> of recommendations on extensions of indications</strong></h3> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Blincyto</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">blinatumomab</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Amgen Europe B.V.</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop/refusal-change-marketing-authorisation-blincyto-blinatumomab_en.pdf" target="_blank" type="application/pdf; length=77821">Questions and answers on Blincyto</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Opdivo</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">nivolumab</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Bristol-Myers Squibb Pharma EEIG</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop/refusal-change-marketing-authorisations-opdivo-nivolumab-yervoy-ipilimumab_en-0.pdf" target="_blank" type="application/pdf; length=80065">Questions and answers on Opdivo</a> </span> </td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="height:25px" width="35%"><strong>Name of medicine</strong></th> <th style="height:25px">Yervoy</th> </tr></thead><tbody><tr><td style="height:25px" width="35%">INN</td> <td style="height:25px">ipilimumab</td> </tr><tr><td width="35%">Marketing-authorisation applicant</td> <td>Bristol-Myers Squibb Pharma EEIG</td> </tr><tr><td>More information</td> <td> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/smop/refusal-change-marketing-authorisations-opdivo-nivolumab-yervoy-ipilimumab_en.pdf" target="_blank" type="application/pdf; length=80065">Questions and answers on Yervoy</a> </span> </td> </tr></tbody></table><p> </p> <h3>Update on valsartan review</h3> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th width="35%">Name of medicine</th> <th>Sartan medicines</th> </tr></thead><tbody><tr><td width="35%">INN</td> <td>valsartan, candesartan, irbesartan, losartan and olmesartan</td> </tr><tr><td width="35%">Marketing-authorisation holder</td> <td>various companies</td> </tr><tr><td>More information</td> <td><a href="/pages/news_and_events/news/2018/09/news_detail_003023.xml">Valsartan: review of impurities extended to other sartan medicines</a></td> </tr></tbody></table><p> </p> <h3>Withdrawal of initial marketing authorisation applications</h3> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th width="35%">Name of medicine</th> <th>Entolimod TMC</th> </tr></thead><tbody><tr><td width="35%">INN</td> <td>entolimod</td> </tr><tr><td width="35%">Marketing-authorisation holder</td> <td>TMC Pharma Services Ltd</td> </tr><tr><td>More information</td> <td><img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" style="font-size:16.02px; background-color:rgb(235, 235, 235)" title="application/pdf" /><span style="font-size:16.02px; background-color:rgb(235, 235, 235)"> </span><a href="https://www.ema.europa.eu/en/medicine-qa/questions-answers-entolimod-tmc-0">Questions and answers on Entolimod TMC</a></td> </tr></tbody></table><p> </p> <table border="0" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th width="35%">Name of medicine</th> <th>Treprostinil SciPharm Sàrl</th> </tr></thead><tbody><tr><td width="35%">INN</td> <td>treprostinil</td> </tr><tr><td width="35%">Marketing-authorisation holder</td> <td>SciPharm Sàrl</td> </tr><tr><td>More information</td> <td><img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" style="font-size:16.02px; background-color:rgb(235, 235, 235)" title="application/pdf" /><a class="pdf" href="/documents/document_library/Medicine_QA/2018/09/WC500255708.pdf">Questions and answers on Treprostinil SciPharm Sàrl</a></td> </tr></tbody></table><p> </p> <h3>Other updates</h3> <table border="0" cellpadding="0" cellspacing="0" style="height:45px" width="100%"><tbody><tr><td>Recommendations on eligibility to PRIME scheme</td> </tr><tr><td style="height:21px"> <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/chmp-annex/scientific-advice-protocol-assistance-adopted-during-chmp-meeting-17-20-september-2018_en.pdf" target="_blank" type="application/pdf; length=138886">Scientific advice and protocol assistance</a> </span> </td> </tr></tbody></table></div> </div> </div>


Portugal to also benefit from EU-US mutual recognition agreement for inspections, , 20/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The <a href="/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements">mutual recognition agreement</a> between the European Union (EU) and the <a href="/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/united-states">United States</a> (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress. The <a href="https://www.fda.gov/">US Food and Drug Administration</a> (FDA) confirmed on 14 September 2018 the capability of one additional EU Member State (Portugal) to carry out <a href="/en/human-regulatory/research-development/compliance/good-manufacturing-practice">good manufacturing practice</a> (GMP) inspections at a level equivalent to the US. There are now a total of 15 Member States whose inspection results the FDA can rely on to replace their own inspections.</p> <p>In June 2017, the European Commission confirmed that the FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. Since 1 November 2017, EU Member States and the European Medicines Agency (EMA) can rely on inspection results from the FDA to replace their own inspections. On 1 November 2017, the FDA confirmed the capability of eight EU Member States. Four further EU Member States were recognised by the FDA on 1 March 2018 and two on 1 June 2018.</p> <p>Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track.</p> <p>The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU national competent authorities, EMA and the FDA have been auditing and assessing the respective supervisory systems since May 2014, and are working closely together to reach the agreement's milestones.</p> </div> </div> </div>


EMA's Committee for Medicinal Products for Human Use (CHMP) elects new chair, , 18/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p><img alt="Harald Enzmann CHMP Chair" src="/sites/default/files/Harald_Enzmann.jpg" style="float:left; margin-left:15px; margin-right:15px" />At its September 2018 meeting, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) elected Harald Enzmann from Germany as its new chair, for a three-year mandate starting on 21 September 2018. Dr Enzmann will replace Dr Tomas Salmonson, senior scientific advisor at the Swedish Medicinal Products Agency (MPA), who will retire as chair after the September 2018 meeting, having served the maximum of two three-year mandates at the helm of the committee.</p> <p>Dr Enzmann is a medical doctor. He works for the <a href="https://www.bfarm.de/EN/Home/home_node.html">Federal Institute for Drugs and Medical Devices (BfArM)</a> in Germany, where he is Head of European and International Affairs. Dr Enzmann has been a member of the CHMP since 2005 and its vice-chair since October 2016.</p> <p>“The CHMP is at the cutting edge of medical progress. With science evolving at such a fast pace, our challenge will be to achieve a balance between being agile to find solutions to emerging scientific or regulatory issues and being consistent with previous decisions,” said Harald Enzmann. “As chair, I will try to elicit in a constructive way the committee members' views, encourage their involvement and structure our scientific discussions to foster consensual decision-making.”</p> <p>The CHMP is the committee at EMA in charge of the scientific evaluation of new medicines. It was set up in 2004 and replaced the Committee for Proprietary Medicinal Products (CPMP).</p> <p>The CHMP will elect a new vice-chair at its October 2018 meeting.</p> <p><i>*Start of mandate updated on 20 September 2018</i></p> </div> </div> </div>


Valsartan: review of impurities extended to other sartan medicines, , 21/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency (EMA) is expanding its <a href="/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity" style="background-color:rgb(255, 255, 255); font-size:14.634px; font-weight:normal">review of impurities in valsartan</a><span style="color:rgb(0, 0, 0); font-size:14.634px; font-weight:normal"> following the detection of very low levels of N-nitrosodiethylamine (NDEA) in another active substance, losartan, made by Hetero Labs in India.</span></p> <p>As a result of the detection of this impurity by German authorities, the review will now include medicines containing four other 'sartans', namely candesartan, irbesartan, losartan and olmesartan.</p> <p>Like valsartan, these active substances have a specific ring structure (tetrazole) whose synthesis could potentially lead to the formation of impurities such as NDEA. Other medicines of the class which do not have this ring are not included in the review.</p> <p>Both NDEA and a related compound N-nitrosodimethylamine (NDMA) are classified as probable human carcinogens (substances that could cause cancer). How these impurities came to be present during the manufacture of sartans is yet to be fully established and is being evaluated in the ongoing review.</p> <p>Based on the trace amounts of NDEA seen so far in one batch of losartan from Hetero Labs, there is no immediate risk to patients. Patients are therefore advised not to stop taking losartan or other sartan medicines without speaking to their doctor.</p> <p>Further tests are required to determine the extent of the contamination and whether impurities are present in sartan medicines above levels that can be considered acceptable.</p> <p>This review was started when unacceptable levels of NDMA were found in some valsartan medicines, which have now been recalled in the EU. Subsequently, NDEA was detected in some of the recalled valsartan products.</p> <p>The extension of the review to other sartans is precautionary. EMA is working closely with national authorities, international partners and <a href="https://www.edqm.eu/">EDQM</a> to gather data on these medicines as quickly as possible.</p> <p>EMA will continue <a href="/en/medicines/human/referrals/sartan-medicines">providing updates</a> as more information becomes available and will take any necessary actions to protect patients' health.</p> <hr /><p><b>More about the medicine</b></p> <p>Candesartan, irbesartan, losartan, olmesartan and valsartan belong to a class of medicines known as angiotensin-II-receptor antagonists (also known as sartans).</p> <p>The medicines are used to treat patients with hypertension (high blood pressure) and those with heart failure or who have had a recent heart attack. They work by blocking the action of angiotensin II, a hormone that constricts blood vessels and causes blood pressure to rise.</p> <p><b>More about the procedure</b></p> <p>The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under <a href="/en/human-regulatory/post-authorisation/referral-procedures">Article 31 of Directive 2001/83/EC</a>. On 20 September 2018, the review was extended to include medicines containing candesartan, irbesartan, losartan and olmesartan.</p> <p>The review is being carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency's opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.</p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/valsartan-review-impurities-extended-other-sartan-medicines_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Valsartan: review of impurities extended to other sartan medicines <small class="ema-u-color-grey-2"> (PDF/68.11 KB) </small> <small class="ema-u-color-epar-red"> (updated)</small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 21/09/2018 <br/> Last updated: 21/09/2018 <br/> EMA/641563/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


New medicine for the prevention of migraine, , 21/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><h4>Monoclonal antibody Emgality recommended for marketing authorisation</h4> <p>The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Emgality (galcanezumab), a monoclonal antibody for the prevention of migraine. Emgality belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks.</p> <p>It is estimated that approximately 15% of the population in the European Union suffers from migraine. Patients experience recurrent episodes of intense, throbbing headache, most often only on one side of the head. Sometimes, the pain is preceded by visual or sensory disturbances known as an 'aura'. Many people also experience nausea, vomiting and increased sensitivity to light or sound. Migraine can substantially impair a patient's ability to function physically, at work or school, and socially.</p> <p>The exact cause of migraine is unknown, but it is believed to be a neurovascular disorder with disease mechanisms both within the brain and the blood vessels of the head. It is most frequent in women and has a strong genetic component.</p> <p>Emgality will be available as a solution for injection intended only for patients who have at least 4 migraine days per month. The benefits and safety of Emgality were studied in three pivotal trials involving 1,780 patients with episodic migraine and 1,117 with chronic migraine. After six months of treatment, patients with episodic migraine showed a reduction of 1.9 monthly migraine days on average compared to placebo. For patients with chronic migraine the reduction was 2 days. The most common side effects are pain and reactions at the injection site, vertigo and constipation.</p> <p>Emgality is the second monoclonal antibody therapy for the prevention of migraine to be recommended for authorisation, following the positive opinion for Aimovig (erenumab) in May 2018. There is no cure for migraine and these two medicines widen the therapeutic options for this disease. There are other available treatments to tackle the symptoms and reduce the frequency of migraine days. However, existing preventative treatments do not always work well and may have unpleasant side effects.</p> <p>The opinion adopted by the CHMP is an intermediary step on Emgality's path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.</p> <hr /><p><b>Note:</b></p> <ul><li>The applicant for Emgality is Eli Lilly Nederland B.V.</li> </ul></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/new-medicine-prevention-migraine_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> New medicine for the prevention of migraine <small class="ema-u-color-grey-2"> (PDF/74.96 KB) </small> <small class="ema-u-color-epar-red"> (updated)</small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 21/09/2018 <br/> Last updated: 21/09/2018 <br/> EMA/CHMP/639488/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


New gene therapy for rare inherited disorder causing vision loss recommended for approval, , 21/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><h4>Luxturna is the first treatment option for hereditary retinal dystrophy with mutations of the RPE65 gene</h4> <p>The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for the gene therapy Luxturna (voretigene neparvovec), for the treatment of adults and children suffering from inherited retinal dystrophy caused by RPE65 gene mutations, a rare genetic disorder which causes vision loss and usually leads to blindness.</p> <p>The mutations of the RPE65 gene, which encodes one of the enzymes involved in the biochemistry of light capture by the cells of the retina, hinder the patient's ability to detect light. It is a severely debilitating disease, characterised by a progressive loss of vision. Most patients will be blind by the time they are young adults. There is currently no treatment for this disease; support to patients is limited to measures allowing the management of the disease such as aids for low vision.</p> <p>Luxturna is meant for patients with confirmed biallelic mutations of the RPE65 gene (i.e. patients who have inherited the mutation from both parents) and who have sufficient viable retinal cells. It is the first gene therapy to be recommended for approval for a retinal disease. Luxturna works by delivering a functional RPE65 gene into the cells of the retina through a single retinal injection, which restores the production pathway for the required enzyme thereby improving the patient's ability to detect light.</p> <p>Luxturna was studied in 41 patients. In the main clinical trial supporting the approval of Luxturna, patients treated with the medicine showed a significant improvement of night vision, one of the typical symptoms of the disease, after one year, while no improvement was seen in the control group. The most common side effects were conjunctival hyperaemia (eye redness), cataracts and increased intraocular pressure.</p> <p>Given the novelty of the treatment and the limited number of treated patients, the CHMP requires the company to ensure the long-term follow-up of patients to confirm Luxturna's continuing efficacy and safety. Follow-up studies were agreed, including a post-authorisation safety study (PASS) based on a disease registry in patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations, as well as a 15-year follow-up programme of efficacy and safety outcomes for all patients treated in the clinical programme.</p> <p>The CHMP's opinion is based on the assessment by EMA's expert committee on Advanced Therapy Medicinal Products (ATMPs), the Committee for Advanced Therapies (CAT). Luxturna was designated as an orphan medicine and an ATMP and EMA provided protocol assistance to the applicant during the development of the medicine. </p> <p>The opinion adopted by the CHMP is an intermediary step on Luxturna's path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once the marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.</p> <hr /><p><b>Notes:</b></p> <ul><li>The applicant for Luxturna is Spark Therapeutics Ireland Ltd.</li> <li>As always at time of approval, EMA's Committee for Orphan Medicinal Products (COMP) will review the orphan designation to determine whether the information available to date allows maintaining Luxturna's orphan status and granting this medicine ten years of market exclusivity.</li> </ul></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/new-gene-therapy-rare-inherited-disorder-causing-vision-loss-recommended-approval_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> New gene therapy for rare inherited disorder causing vision loss recommended for approval <small class="ema-u-color-grey-2"> (PDF/71.23 KB) </small> <small class="ema-u-color-epar-red"> (updated)</small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 21/09/2018 <br/> Last updated: 21/09/2018 <br/> EMA/CHMP/635637/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


New medicine to treat infections in adults, , 21/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Vabomere (meropenem trihydrate/vaborbactam), a new treatment option against the following infections in adults:</p> <ul><li>Complicated urinary tract infection, including pyelonephritis, a sudden and severe infection causing the kidneys to swell and which may permanently damage them;</li> <li>Complicated intra-abdominal infection;</li> <li>Hospital-acquired pneumonia, including ventilator associated pneumonia;</li> <li>Bacteria in the blood associated with any of the infections listed above;</li> <li>Infections due to aerobic Gram-negative organisms in adults with limited treatment options.</li> </ul><p>The lack of availability of medicines to treat patients with infections caused by resistant bacteria has become a major problem in recent years. It is estimated that at least 25,000 patients in the European Union (EU) die each year from infections due to bacteria that are resistant to many medicines.</p> <p>Vabomere is a fixed combination of vaborbactam, a new beta-lactamase inhibitor and meropenem, a broad-spectrum antibiotic belonging to the class of carbapenems that is already approved for use in the EU. It is a powder for concentrate for solution for infusion (drip into a vein).</p> <p>Resistance to carbapenems has been increasing lately, in particular in Gram-negative bacteria, and is of major concern. Beta-lactamases are enzymes involved in bacterial resistance to these antibiotics. By inhibiting the action of beta-lactamases, vaborbactam protects meropenem from being inactivated and restores its activity against many, but not all, carbapenem-resistant pathogens.</p> <p>In the clinical development program, the exposure to vaborbactam at the recommended dose was shown to be sufficient to protect the activity of meropenem against carbapenem-resistant Enterobacteriaceae. The CHMP also agreed that the studies did not indicate any major concerns regarding the safety profile of meropenem-vaborbactam.</p> <p>EMA contributes to the European and global effort to tackle antimicrobial resistance. A major area of activity is to create an environment that stimulates and facilitates the development of new antimicrobials. The Agency's activities also include the monitoring and analysis of data on antimicrobials to guide policy and research, as well as the promotion of their responsible use.</p> <p>The opinion adopted by the CHMP is an intermediary step on Vabomere's path to patient access. The opinion will now be sent to the European Commission­ for the adoption of a decision on an EU-wide marketing authorisation. Once the marketing authorisations has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.</p> <hr /><p><b>Note:</b></p> <ul><li>The applicant for is Rempex London Ltd.</li> </ul></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/new-medicine-treat-infections-adults_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> New medicine to treat infections in adults <small class="ema-u-color-grey-2"> (PDF/73.4 KB) </small> <small class="ema-u-color-epar-red"> (updated)</small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 21/09/2018 <br/> Last updated: 21/09/2018 <br/> EMA/CHMP/640311/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


EMA to launch new corporate website on 27 September 2018, , 25/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency (EMA) will launch a new version of its corporate website (<a href="http://www.ema.europa.eu">www.ema.europa.eu</a>) on 27 September 2018.</p> <p>The new website will have an improved search, cleaner display on mobile devices, simpler URLs and an updated visual design. These improvements are intended to address important issues with the current website, as highlighted by users.</p> <p>The current website content and structure will be unchanged. The current URLs for every page and document will also continue to work, thanks to redirects from the current site to the new one for every page and document. However, EMA encourages users who have bookmarked any current URLs to consider updating these after the new website goes live.</p> <p>EMA is launching its new corporate website now after careful planning to ensure that the site was moved to a new platform before its <a class="ecl-link" href="https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/relocation-amsterdam">Relocation to Amsterdam</a> next year.</p> <p>The project to migrate the website was carried out in collaboration with the <a href="https://ec.europa.eu/info/departments/informatics" target="_blank">European Commission’s Directorate General for Informatics (DIGIT)</a>, who will also host and maintain the new website on behalf of EMA.</p> <p>The corporate website is EMA’s main public communication channel with around 600,000 visitors a month.</p> </div> </div> </div>


Harnessing the potential of real world data through a ‘learning healthcare system’, , 27/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>Real world data (RWD) hold the promise to substantially increase the effectiveness and efficiency of all processes in the development and utilisation of medicines, from research and development, to regulatory decision-making, pricing and reimbursement decisions to use in medical practice. However, to realise the full potential of RWD requires a ‘learning healthcare system’, write the European Medicines Agency’s (EMA) <a class="ecl-link" href="https://www.ema.europa.eu/en/executive-director">Executive Director</a> and Senior Medical Officer, as well as heads of three national EU agencies, and academia, payer, and Organisation for Economic Co-operation and Development (OECD) representatives, in a <a href="http://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.1226">paper published in Clinical Pharmacology and Therapeutics</a>.</p> <p>A ‘learning healthcare system’, based on electronic health records and other routinely collected healthcare data, would allow RWD to be continuously fed into the system, ensuring that with every new patient treated, we know more overall about the practice of medicine.</p> <p>Such judicious use of RWD would complement the traditional evidence from randomised clinical trials, for  the benefit of all stakeholders involved in the development and use of medicines, from patients and healthcare professionals to regulators, health-technology assessment bodies, payers, academic researchers and research-based pharmaceutical industry. The authors highlight the need to tear down the current barrier between the structured research setting and everyday medical practice, and instead use data gathered in everyday practice to generate new knowledge and answer research questions.</p> <p>To achieve this, the healthcare systems must be ready in terms of technology to collect data, of a methodology to analyse information and governance in particular regarding aspects such as protection of personal data, consent, ethics and data access.</p> <p>The authors therefore call for all stakeholders to join in a coordinated effort, at international level, to accelerate the implementation of such a model of a ‘learning healthcare system’.</p> </div> </div> </div>


EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan, , 28/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><h4>EMA and national authorities considering impact on other active substances produced at the site</h4> <p>An inspection by EU authorities in collaboration with <a href="https://www.edqm.eu/">EDQM</a> has found that Zhejiang Huahai did not comply with good manufacturing practice (GMP) in the manufacture of valsartan at the Chuannan site in Linhai, China.</p> <p>As a result, a statement of non-compliance for the manufacture of valsartan has been issued and the site is no longer authorised to produce valsartan (and its intermediates) for EU medicines. This means that marketing authorisation holders in the EU are prohibited from using valsartan from the site for the production of medicines.</p> <p>This action comes after <a href="https://www.ema.europa.eu/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity">product recalls</a> and the subsequent suspension of the company’s CEP* for valsartan (a certificate of compliance with European standards for quality testing) in July 2018. This already prohibited the supply of the company’s valsartan in the EU due to the presence of an impurity N-nitrosodimethylamine (NDMA).</p> <p>The latest European inspection, which focused on the manufacture of valsartan and was completed in September 2018, found several weaknesses at Zhejiang Huahai, including deficiencies in the way the company investigated the presence of NDMA and another impurity N-nitrosodiethylamine (NDEA) in its valsartan products.</p> <p>The non-compliance statement, which applies only to the manufacture of valsartan, is available on the <a href="http://eudragmdp.ema.europa.eu/inspections/displayWelcome.do;jsessionid=fgh3S2RTppG2tHZZQ6GSJrYsDhMP0lR1YGfzwVyyxJtcQFt6hZDf!899440497">EudraGMP website</a>.</p> <p>The site has recently also been inspected by the US Food and Drug Administration (FDA), which has issued an <a href="https://www.accessdata.fda.gov/cms_ia/importalert_189.html">import alert</a> stopping all active substances produced by Zhejiang Huahai’s Chuannan site and all medicines containing those active substances from entering the United States. FDA has not announced additional product recalls other than those already in place for valsartan medicines, similar to the recalls in the EU.</p> <p>EMA and national authorities in the EU are now actively considering all available evidence, including the outcomes of the European and US inspections, as part of the ongoing process of evaluating the Zhejiang Huahai manufacturing site. This will determine what further EU action may be required for other active substances produced by the site.</p> <p>The detection of NDMA (a substance that could cause cancer) in valsartan from Zhejiang Huahai led to an <a href="https://www.ema.europa.eu/medicines/human/referrals/sartan-medicines">EU-wide review</a> of valsartan medicines, which was subsequently <a href="https://www.ema.europa.eu/en/news/valsartan-review-impurities-extended-other-sartan-medicines">extended</a> to other sartans medicines.</p> <p>This review is still ongoing. EMA will continue working with national authorities, international partners and EDQM and will provide updates as more information becomes available.</p> <p><strong>More about the medicine</strong></p> <p>Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own or in combination with other <a href="https://www.ema.europa.eu/en/glossary/active-substance" target="_blank" title="The substance responsible for the activity of a medicine.">active substances</a>.</p> <p><strong>More about the procedure</strong></p> <p>The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under <a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000150.jsp&mid=WC0b01ac05800240d0">Article 31 of Directive 2001/83/EC</a>. On 20 September 2018, the review was extended to include medicines containing candesartan, irbesartan, losartan and olmesartan.</p> <p>The review is being carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.</p> <div>  <hr align="left" size="1" width="33%" /><div id="ftn1"> <p>*CEP: <a href="https://www.edqm.eu/en/certificate-suitability-new-applications">certificate of suitability to the monographs of the European Pharmacopoeia</a></p> </div> </div> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/eu-inspection-finds-zhejiang-huahai-site-non-compliant-manufacture-valsartan_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan <small class="ema-u-color-grey-2"> (PDF/197.26 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 28/09/2018 <br/> EMA/671501/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Update on review of valsartan medicines: risk from NDMA remains low, a related substance NDEA also being investigated, , 13/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency (EMA) has updated its calculation of the risk from valsartan medicines containing N‑nitrosodimethylamine (NDMA), taking into account results from latest tests on the active substance from Zhejiang Huahai.</p> <p>In line with EMA's previous assessment, the life-time risk of cancer is considered low and is estimated to be in the order of 1 in 5,000 for an adult patient who had taken an affected valsartan medicine at the highest dose (320 mg) every day from July 2012 to July 2018.</p> <p>EMA's risk assessment is based on the average levels of NDMA in the active substance produced by Zhejiang Huahai since 2012 (when the company changed its manufacturing process) and on the assumption that all the NDMA is transferred to the final product.</p> <p>Patients who have taken treatments with lower doses or for shorter lengths of time will be at a lower risk. The risk will also be lower for patients who have taken valsartan produced by Zhejiang Tianyu, which had smaller amounts of NDMA than valsartan produced by Zhejiang Huahai.</p> <p>The low risk estimate is to some extent supported by a Danish study<sup>1</sup> which tracked patients who had taken medicines containing valsartan from Zhejiang Huahai over the past 6 years. However, the authors note that patients were followed up for a relatively short period (4.6 years on average).</p> <p>In addition to NDMA, EMA is assessing the impact of a related substance, N‑nitrosodiethylamine (NDEA), which has been detected in valsartan made by Zhejiang Huahai using its previous manufacturing process before changes were introduced in 2012. Both NDEA and NDMA belong to the class of nitrosamines and are classified as probable human carcinogens (substances that could cause cancer).</p> <p>Data on levels of NDEA are currently very limited, and EMA will provide further information on whether its presence impacts the risk assessment once more information becomes available.</p> <p>Although the review covers all valsartan medicines, the immediate focus has been on medicines containing the active substance manufactured by <a href="/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity">Zhejiang Huahai</a> and <a href="/en/news/update-medicines-containing-valsartan-zhejiang-tianyu">Zhejiang Tianyu</a> where unacceptable levels of NDMA have been confirmed. EU authorities have now carried out inspections of the manufacturing sites of both companies in China and will consider the findings.</p> <p>Medicines containing valsartan from Zhejiang Huahai and Zhejiang Tianyu are no longer being distributed in the EU or have been recalled. Both companies are not currently authorised to produce valsartan for medicines in the EU.</p> <p>EMA continues to work closely with national authorities, international partners and EDQM to gather the necessary information which would allow the Agency to have a better understanding of why impurities were present in the active substance in the first place.</p> <p>Based on the final outcome of the review, authorities in the EU will take necessary measures to ensure that similar problems do not occur in future.</p> <hr /><p><b>More about the medicine</b></p> <p>Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own or in combination with other active substances.</p> <p>Medicines containing valsartan as the only active substance have been authorised in the EU via national authorities. <a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByKey&alreadyLoaded=true&isNewQuery=true&status=Authorised&keyword=valsartan&searchType=inn&taxonomyPath=&treeNumber=&searchGenericType=generics">Nine products</a> containing valsartan in combination with other active substances have been authorised centrally via EMA.</p> <p><b>More about the procedure</b></p> <p>The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under <a href="/en/human-regulatory/post-authorisation/referral-procedures">Article 31 of Directive 2001/83/EC</a>.</p> <p>The review is being carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency's opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.</p> <hr /><p><sup>1</sup> Pottegard A, Kristensen K, Ernst MT, Johansen NB, Quartorolo P, Hallas J. Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study. <a href="https://www.bmj.com/content/362/bmj.k3851?ijkey=ec3a867343b40c9dc6f4fd1f37cc4637b576c5e2&keytype2=tf_ipsecsha">BMJ 2018;362:k3851</a></p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/update-review-valsartan-medicines_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Update on review of valsartan medicines <small class="ema-u-color-grey-2"> (PDF/70.49 KB) </small> <small class="ema-u-color-epar-red"> (updated)</small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 13/09/2018 <br/> Last updated: 13/09/2018 <br/> EMA/585263/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan: EMA and national authorities considering impact on other active substances produced at the site, , 28/09/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>An inspection by EU authorities in collaboration with <a href="https://www.edqm.eu/">EDQM</a> has found that Zhejiang Huahai did not comply with good manufacturing practice (GMP) in the manufacture of valsartan at the Chuannan site in Linhai, China.</p> <p>As a result, a statement of non-compliance for the manufacture of valsartan has been issued and the site is no longer authorised to produce valsartan (and its intermediates) for EU medicines. This means that marketing authorisation holders in the EU are prohibited from using valsartan from the site for the production of medicines.</p> <p>This action comes after <a href="https://www.ema.europa.eu/en/news/ema-reviewing-medicines-containing-valsartan-zhejiang-huahai-following-detection-impurity">product recalls</a> and the subsequent suspension of the company’s CEP* for valsartan (a certificate of compliance with European standards for quality testing) in July 2018. This already prohibited the supply of the company’s valsartan in the EU due to the presence of an impurity N-nitrosodimethylamine (NDMA).</p> <p>The latest European inspection, which focused on the manufacture of valsartan and was completed in September 2018, found several weaknesses at Zhejiang Huahai, including deficiencies in the way the company investigated the presence of NDMA and another impurity N-nitrosodiethylamine (NDEA) in its valsartan products.</p> <p>The non-compliance statement, which applies only to the manufacture of valsartan, is available on the <a href="http://eudragmdp.ema.europa.eu/inspections/displayWelcome.do;jsessionid=fgh3S2RTppG2tHZZQ6GSJrYsDhMP0lR1YGfzwVyyxJtcQFt6hZDf!899440497">EudraGMP website</a>.</p> <p>The site has recently also been inspected by the US Food and Drug Administration (FDA), which has issued an <a href="https://www.accessdata.fda.gov/cms_ia/importalert_189.html">import alert</a> stopping all active substances produced by Zhejiang Huahai’s Chuannan site and all medicines containing those active substances from entering the United States. FDA has not announced additional product recalls other than those already in place for valsartan medicines, similar to the recalls in the EU.</p> <p>EMA and national authorities in the EU are now actively considering all available evidence, including the outcomes of the European and US inspections, as part of the ongoing process of evaluating the Zhejiang Huahai manufacturing site. This will determine what further EU action may be required for other active substances produced by the site.</p> <p>The detection of NDMA (a substance that could cause cancer) in valsartan from Zhejiang Huahai led to an <a href="https://www.ema.europa.eu/medicines/human/referrals/sartan-medicines">EU-wide review</a> of valsartan medicines, which was subsequently <a href="https://www.ema.europa.eu/en/news/valsartan-review-impurities-extended-other-sartan-medicines">extended</a> to other sartans medicines.</p> <p>This review is still ongoing. EMA will continue working with national authorities, international partners and EDQM and will provide updates as more information becomes available.</p> <p><strong>More about the medicine</strong></p> <p>Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own or in combination with other <a href="https://www.ema.europa.eu/en/glossary/active-substance" target="_blank" title="The substance responsible for the activity of a medicine.">active substances</a>.</p> <p><strong>More about the procedure</strong></p> <p>The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under <a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000150.jsp&mid=WC0b01ac05800240d0">Article 31 of Directive 2001/83/EC</a>. On 20 September 2018, the review was extended to include medicines containing candesartan, irbesartan, losartan and olmesartan.</p> <p>The review is being carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.</p> <div>  <hr align="left" size="1" width="33%" /><div id="ftn1"> <p>*CEP: <a href="https://www.edqm.eu/en/certificate-suitability-new-applications">certificate of suitability to the monographs of the European Pharmacopoeia</a></p> </div> </div> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/eu-inspection-finds-zhejiang-huahai-site-non-compliant-manufacture-valsartan_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan <small class="ema-u-color-grey-2"> (PDF/197.26 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 28/09/2018 <br/> EMA/671501/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Boosting the development of medicines for children, , 02/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency (EMA) and the <a href="https://ec.europa.eu/info/departments/health-and-food-safety_en">European Commission’s Directorate-General for Health and Food Safety (DG SANTE)</a> have published today a <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/report/european-medicines-agency-european-commission-dg-health-food-safety-action-plan-paediatrics_en.pdf" target="_blank" type="application/pdf; length=128413">joint action plan to support the development of medicines for children in Europe</a> </span> </p> <p>The action plan addresses challenges identified by the European Commission’s <a href="https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf" style="background-color:rgb(255, 255, 255)">ten-year report on the implementation of the Paediatric Legislation</a>. It also takes into account the ideas on <a href="/documents/report/how-better-apply-paediatric-legislation-boost-development-medicines-children-report-multi_en.pdf" style="background-color:rgb(255, 255, 255)">how to better apply the Paediatric Regulation to boost the development of medicines for children</a> collected during the multi-stakeholder workshop organised by EMA and the European Commission in March 2018.</p> <p>The actions in the plan are clustered around five key areas:</p> <ul><li>identifying paediatric medical needs;</li> <li>strengthening cooperation between decision makers;</li> <li>ensuring timely completion of paediatric investigation plans (PIPs);</li> <li>improving the handling of PIP applications;</li> <li>increasing transparency around paediatric medicines.</li> </ul><p>It is expected that the implementation of these actions will increase the efficiency of paediatric regulatory processes in the current legal framework and boost the availability of medicines for children.</p> <p>The plan was originally intended to be completed within a two-year timeframe. However, due to the impact of Brexit and the Agency’s relocation to the Netherlands, some actions are not expected to be completed by the end of 2020, as specified in the plan. The plan will be updated over time as necessary, depending on prioritisation and availability of resources.</p> <h4><strong>More information on the Paediatric Regulation</strong></h4> <p>The<a class="ecl-link" href="https://www.ema.europa.eu/en/human-regulatory/overview/paediatric-medicines/paediatric-regulation">Paediatric Regulation</a> came into force in the EU in 2007 to encourage manufacturers to research and develop medicines for children’s specific therapeutic needs by using a system of rewards and obliging developers to specifically plan the development of their medicine for children (e.g. by integrating it into the development for adults) and submit a corresponding PIP. PIPs are scientifically reviewed and agreed by the EMA’s Paediatric Committee (PDCO), which  was also introduced by the same legislation. </p> <p>In 2017, the European Commission published a <a href="https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf">ten-year report on the implementation of the Paediatric Regulation</a> which showed an overall success with an increase in authorised medicines for children.  In therapeutic areas such as infectious diseases and rheumatology, new indications for medicines led to positive changes in the way children are treated. In other areas (e.g. oncology, neonatology), the Regulation was less effective. The action plan suggests concrete actions to further boost the development of paediatric medicines by addressing the various areas as outlined above under the current legal framework.</p> </div> </div> </div>


EMA Management Board: highlights of October 2018 meeting, , 05/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p><strong>EMA mid-year report 2018</strong></p> <p>At its 4 October 2018 meeting in London, the Management Board of the European Medicines Agency (EMA) heard an update on the Agency’s activities in the first half of 2018.</p> <p>In human medicine, EMA recommended the first two CAR-T cell medicines for approval in the European Union (EU). These innovative medicines present a new approach in the treatment of cancer and were also the first medicines supported through EMA’s PRIority MEdicines (PRIME) scheme to receive positive opinions from EMA’s Committee for Medicinal Products for Human Use (CHMP).</p> <p>The number of new initial evaluation applications for human medicines received in the first half of 2018 was 30% higher than that received during the same period in 2017 (47 in the first half 2018 versus 36 in the first half of 2017).</p> <p>In veterinary medicine, initial evaluation applications remained at the same level as in the first half of 2017, with seven applications received. The number of requests for scientific advice for veterinary medicines increased to 16 in the first half of 2018 compared to 14 during the same period in 2017.</p> <p>The number of transfers of marketing authorisation applications has seen a six-fold increase compared to 2017, primarily due to Brexit-related transfers (232 in the first half of 2018, compared to 36 in the same period in 2017).</p> <p>EMA’s mid-year report will be published on the EMA website shortly.</p> <p><strong>Report from the Scientific Advice Working Party</strong></p> <p>The Chair of the Scientific Advice Working Party (SAWP), Rob Hemmings, briefed the Board on the activities of the working party, highlighting the constant increase in scientific advice procedures over the past ten years. He also underlined the continuing interest of applicants for the qualification of novel methodologies procedure and the parallel scientific advice with health technology assessment (HTA) bodies. The SAWP’s role in informing EMA committee decisions on eligibility to the PRIME scheme was also highlighted.</p> <p>“Scientific advice is an important tool for EMA and the network to clarify regulatory requirements for the development of new medicines for the benefit of patients,” said Mr Hemmings. “We are helping to ensure that companies generate robust evidence on their medicines development and a key challenge in the future will be to have the right expertise on the working party to keep pace with rapidly evolving innovation in pharmaceutical development.”</p> <p>The SAWP is an EMA working party which upon request advises medicine developers on the use of the best methods to develop their medicine and collect the most robust data. Its members are appointed according to the areas of expertise needed. Assessing whether the generated data support a positive benefit/risk for the product concerned is always done independently by the CHMP at time of marketing authorisation application.</p> <p><strong>Ten-year study on procedures for authorisation and monitoring of human medicines</strong></p> <p>As part of the EU’s ongoing drive to make sure that its laws are fit for purpose, the European Commission has commissioned a study to examine the procedures for authorisation and monitoring of medicines for human use.</p> <p>The focus of the study, which will be conducted by Ernst & Young, is on the operation of the regulatory procedures, and in particular their effectiveness, efficiency, relevance to the objectives laid down in the current EU legislative framework, as well as to check that they are delivering for patients. The Board heard that a report to the European Parliament and the Council of the EU will be published by the European Commission in 2020. Member States, the pharmaceutical industry and representatives of patient and healthcare professional organisations will be asked to contribute to the preparation of the study.</p> <p>EMA’s founding regulation requires that the Agency is evaluated at least every ten years; such an evaluation was last carried out in January 2010.</p> <p><strong>Revision to policy on access to documents</strong></p> <p>Providing <a href="https://www.ema.europa.eu/en/glossary/access-documents" target="_blank" title="Activities relating to public access to European Medicines Agency documents. For more information, see access to documents.">access to documents</a> is an important element in EMA's continued commitment to transparency.</p> <p>The Board was updated on revisions to EMA’s access to documents policy following a public consultation in 2017. The policy describes the rules EMA applies, in accordance with <a href="http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=URISERV%3Al14546" target="_blank">Regulation (EC) No 1049/2001</a>, which gives EU citizens the right to access EU documents.</p> <p>The new version extends the scope of the policy to include documents held by the Agency that are not related to medicinal products. It includes a new table outlining the access rules for these documents and a revised table on access rules for documents related to medicines for human and veterinary use. The policy reiterates that EMA is no longer in a position to process access to documents requests issued from outside the EU.</p> <p><strong>EU </strong><strong>Clinical Trial</strong><strong> Regulation and development of the EU portal and database</strong></p> <p>The Board was updated on the quality and status of the ongoing development of the EU clinical trial portal and database, both of which are being carefully monitored. The Board heard that the development of the auditable release of the portal and database (release 0.7) is complete. The release is now in an intensive phase of pre-testing before formal user acceptance testing (UAT7) can start in early 2019. Taking into account the rate of progress with testing and bug fixing, and the relocation of the Agency, the audit field work will take place once the Agency has settled in Amsterdam, after March 2019. Dependent on successful completion of the audit and review by the Management Board around the end of 2019, the system could be ready to go live later in 2020. </p> <p><strong>Brexit preparations</strong></p> <p>The Board was also updated on the Agency’s ongoing preparations for the withdrawal of the United Kingdom (UK) from the EU. Board members heard that the cooperation with the Netherlands is running smoothly and preparations for both the interim and the permanent buildings are on track. The Board congratulated EMA on the quality and professionalism of its preparatory work so far and acknowledged the heavy workload that the Agency has to deal with.</p> <p>EMA will communicate further on the operational preparations for Brexit shortly.</p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/ema-management-board-highlights-october-2018-meeting_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> EMA Management Board: highlights of October 2018 meeting <small class="ema-u-color-grey-2"> (PDF/75.89 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 05/10/2018 <br/> EMA/678495/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="contact-point-section" id="contact-point-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Contact point</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p class="BodytextAgency">Tel. +44 (0)20 3660 8427<br /><br /> E-mail: <a href="mailto:press@ema.europa.eu">press@ema.europa.eu</a><br /><br /> Follow us on Twitter <a href="http://www.twitter.com/EMA_News">@EMA_News</a></p> </div> </div> </div>


Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use, , 05/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><h4 class="DocsubtitleAgency">New restrictions follow review of disabling and potentially long-lasting side effects</h4> <h4 class="DocsubtitleAgency"></h4> <p>EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics (used by mouth, injection or inhalation) following a review of disabling and potentially long-lasting side effects reported with these medicines. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018.</p> <p>Very rarely, patients treated with fluoroquinolone or quinolone antibiotics have suffered long-lasting and disabling side effects, mainly involving muscles, tendons and bones and the nervous system.   </p> <p>Following its evaluation of these side effects, the PRAC has recommended that some medicines, including all those that contain a quinolone antibiotic, should be removed from the market. This is because they are authorised only for infections that should no longer be treated with this class of antibiotics.</p> <p>The PRAC recommended that the remaining fluoroquinolone antibiotics should:</p> <ul><li><strong>not</strong> be used <ul><li>to treat infections that might get better without treatment or are not severe (such as throat infections);</li> <li>for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);</li> <li>to treat patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic;</li> <li>to treat mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used;</li> </ul></li> <li>be used <strong>with caution</strong> especially for the elderly, patients with kidney problems, patients who have had an organ transplantation or those who are being treated with a systemic corticosteroid. These patients are at higher risk of tendon injury caused by fluoroquinolone and quinolone antibiotics.</li> </ul><p>The PRAC also recommended that healthcare professionals should advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or bones (such as inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling) or the nervous system (such as feeling pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell).</p> <p>Prescribing information of individual fluoroquinolone antibiotics will be updated to reflect the restricted use.</p> <p>The PRAC recommendations will now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion.</p> <div> <p> </p> </div> <hr /><p><strong>More about the medicine</strong></p> <p>Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are active against bacteria of both Gram-negative and Gram-positive classes.</p> <p>The review covered the following medicines: ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin (fluoroquinolone antibiotics); cinoxacin, nalidixic acid, pipemidic acid (quinolone antibiotics).</p> <p>The review concerned only medicines given systemically (by mouth or injection) and inhaled medicines.</p> <p><strong>More about the procedure</strong></p> <p>The review of fluoroquinolones and quinolones was initiated on 9 February 2017 at the request of the German medicines authority (BfArM), under <a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000150.jsp&mid=WC0b01ac05800240d0">Article 31 of Directive 2001/83/EC</a>.</p> <p>The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations. The PRAC recommendations will now be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion.</p> <p>The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States. The new restrictions on the use of fluoroquinolones and quinolones will become applicable after a Commission decision is issued.</p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/fluoroquinolone-quinolone-antibiotics-prac-recommends-restrictions-use_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use <small class="ema-u-color-grey-2"> (PDF/175.92 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 05/10/2018 <br/> EMA/668915/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 October 2018, , 05/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>At its monthly meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded a referral and confirmed its advice in the context of a safety signal evaluation. More information on all safety referrals currently under evaluation is provided in the table below.</p> <p><strong>PRAC recommends restrictions on use of fluoroquinolone and quinolone antibiotics</strong></p> <p>Following a review of disabling and potentially long-lasting but very rare side effects reported with fluoroquinolone and quinolone antibiotics, the PRAC has recommended that they should only be used to treat infections when an antibiotic is essential and other antibiotics cannot be used. Some medicines from this class of antibiotics will be removed from the market because they were only authorised for infections that should no longer be treated with these medicines.</p> <p>The review incorporated the input of patients, healthcare professionals and academics presented at EMA’s <a href="https://www.ema.europa.eu/en/about-us/how-we-work/public-hearings">public hearing</a> on fluoroquinolone and quinolone antibiotics in June 2018. The public hearing allowed the PRAC to hear directly from members of the public about their views on the risks associated with these antibiotics and to explore further measures that could ensure these medicines are used as safely as possible.</p> <p>More information is provided below.</p> <p><strong>PRAC confirms precautionary advice on HIV medicine dolutegravir </strong></p> <p>The PRAC confirmed its <a href="https://www.ema.europa.eu/en/news/new-study-suggests-risk-birth-defects-babies-born-women-hiv-medicine-dolutegravir">precautionary advice</a>  issued earlier this year on the use of dolutegravir in pregnant women and women who can become pregnant. Women who can become pregnant should use effective contraception while taking dolutegravir. In addition, women should undergo pregnancy testing before starting treatment and the medicine should not be used during the first trimester of pregnancy unless there is no alternative.</p> <p>The evaluation assessed preliminary results from a study which found cases of neural tube defects (birth defects of the brain and spinal cord) in babies born to mothers who used dolutegravir during pregnancy. As the study is still ongoing, a further assessment will be carried out once the final results become available next year.</p> </div> </div> </div> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="agenda-section" id="agenda-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Agenda</h3> </div> </div> </div> </div> <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/agenda/agenda-prac-draft-agenda-meeting-1-4-october-2018_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Agenda - PRAC draft agenda of meeting 1-4 October 2018 <small class="ema-u-color-grey-2"> (PDF/613.39 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Draft<br/> <br /> First published: 01/10/2018 <br/> EMA/PRAC/678706/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="ongoing-referrals-section" id="ongoing-referrals-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Ongoing referrals</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><h4> </h4> <table border="1" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="background-color:rgb(227, 227, 227)"> <p>Procedure</p> </th> <th style="background-color:rgb(227, 227, 227)"> <p>Status</p> </th> <th style="background-color:rgb(227, 227, 227)"> <p>Update</p> </th> </tr></thead><tbody><tr><td style="background-color:rgb(255, 255, 255)"> <p>Article-31 procedure: <a class="ecl-link" href="https://www.ema.europa.eu/en/medicines/human/referrals/methotrexate-containing-medicinal-products">Methotrexate containing medicinal products</a></p> </td> <td style="background-color:rgb(255, 255, 255)"> <p>Under evaluation</p> </td> <td style="background-color:rgb(255, 255, 255)"> <p>PRAC adopted a list of outstanding issues to be addressed by marketing-authorisation holders.</p> </td> </tr></tbody></table></div> </div> </div>


Fluoroquinolone and quinolone antibiotics: PRAC recommends new restrictions on use following review of disabling and potentially long-lasting side effects, , 05/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics (used by mouth, injection or inhalation) following a review of disabling and potentially long-lasting side effects reported with these medicines. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018.</p> <p>Very rarely, patients treated with fluoroquinolone or quinolone antibiotics have suffered long-lasting and disabling side effects, mainly involving muscles, tendons and bones and the nervous system.   </p> <p>Following its evaluation of these side effects, the PRAC has recommended that some medicines, including all those that contain a quinolone antibiotic, should be removed from the market. This is because they are authorised only for infections that should no longer be treated with this class of antibiotics.</p> <p>The PRAC recommended that the remaining fluoroquinolone antibiotics should:</p> <ul><li><strong>not</strong> be used <ul><li>to treat infections that might get better without treatment or are not severe (such as throat infections);</li> <li>for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);</li> <li>to treat patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic;</li> <li>to treat mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used;</li> </ul></li> <li>be used <strong>with caution</strong> especially for the elderly, patients with kidney problems, patients who have had an organ transplantation or those who are being treated with a systemic corticosteroid. These patients are at higher risk of tendon injury caused by fluoroquinolone and quinolone antibiotics.</li> </ul><p>The PRAC also recommended that healthcare professionals should advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or bones (such as inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling) or the nervous system (such as feeling pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell).</p> <p>Prescribing information of individual fluoroquinolone antibiotics will be updated to reflect the restricted use.</p> <p>The PRAC recommendations will now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion.</p> <div> <p> </p> </div> <hr /><p><strong>More about the medicine</strong></p> <p>Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are active against bacteria of both Gram-negative and Gram-positive classes.</p> <p>The review covered the following medicines: ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin (fluoroquinolone antibiotics); cinoxacin, nalidixic acid, pipemidic acid (quinolone antibiotics).</p> <p>The review concerned only medicines given systemically (by mouth or injection) and inhaled medicines.</p> <p><strong>More about the procedure</strong></p> <p>The review of fluoroquinolones and quinolones was initiated on 9 February 2017 at the request of the German medicines authority (BfArM), under <a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000150.jsp&mid=WC0b01ac05800240d0">Article 31 of Directive 2001/83/EC</a>.</p> <p>The review has been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations. The PRAC recommendations will now be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion.</p> <p>The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States. The new restrictions on the use of fluoroquinolones and quinolones will become applicable after a Commission decision is issued.</p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/fluoroquinolone-quinolone-antibiotics-prac-recommends-restrictions-use_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use <small class="ema-u-color-grey-2"> (PDF/175.92 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 05/10/2018 <br/> EMA/668915/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Update on EMA’s Brexit preparedness, , 09/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency’s (EMA) Brexit preparedness business continuity plan (BCP) entered into its third phase on 1 October 2018, <a href="https://www.ema.europa.eu/en/news/brexit-preparedness-ema-further-temporarily-scale-back-suspend-activities">as announced at the beginning of August 2018</a>.</p> <p>The temporary suspension or reduction of additional activities in this phase allows the Agency to safeguard core activities related to the evaluation and supervision of medicines while the Agency prepares for the consequences of the <a href="https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit" target="_self">United Kingdom’s (UK) exit from the European Union (EU)</a> - both in terms of the impact on the Agency’s operations, as well as <a href="https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/relocation-amsterdam" target="_self">its physical move to Amsterdam</a>. It will also help the Agency cope with anticipated staff loss.</p> <p>“EMA will now temporarily suspend or scale back additional activities to ensure that resources can be redeployed so that its core activities can continue without interruption and to the same quality,” commented Noël Wathion, EMA’s <a href="https://www.ema.europa.eu/en/about-us/who-we-are/deputy-executive-director-support-services" target="_self">Deputy Executive Director</a>. “Over the next few months, EMA will continue to carefully monitor staff intentions to relocate and the anticipated impact on its activities whilst planning for the critical time period when the Agency will be moving to its new premises in Amsterdam.”</p> <p>The measures announced on 1 August included, among others, the scaling back of guideline development and revision and the putting on hold of non-product related working parties from 1 November 2018. The Agency has now drawn up priority lists of those guidelines and working parties, which will exceptionally continue during BCP phase 3:</p> <ul><li>Work on seven guidelines which address either an urgent public/animal health need, or are necessary to support and facilitate preparations for Brexit or the implementation of new or revised legislation, will continue beyond 1 November 2018;</li> <li>Meetings of product-related working parties will continue as scheduled;</li> <li>All meetings of non-product related working parties have been temporarily put on hold in line with the reduction in the number of guidelines to be processed.</li> </ul><p>Detailed information is available in the <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/other/ema-brexit-preparedness-business-continuity-plan-phase-3-implementation-plan_en.pdf" target="_blank" type="application/pdf; length=105723">BCP phase 3 implementation plan</a> </span> .</p> <p>The Agency anticipates that phase 3 will have to be complemented with additional temporary suspensions/reductions as of 1 January 2019, which will be launched as part of phase 4 of the BCP, in order to put in place the necessary arrangements for the physical move to the Netherlands.</p> <p>Temporary suspension and scaling back of activities is currently scheduled to last until 30 June 2019, but will be reviewed in April 2019, once the Agency has completed its move to its temporary building in Amsterdam.</p> <p><strong>Practical guidance for companies on cut-off dates for UK rapporteur appointments</strong></p> <p>EMA has also published new <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/other/cut-dates-uk-rapporteurship-appointments-pre-post-authorisation-procedures-centrally-authorised_en.pdf" target="_blank" type="application/pdf; length=88557">information for pharmaceutical companies on cut-off dates for appointments of (co)-rapporteurs from the UK </a> </span> for both pre- and post-authorisation activities for centrally authorised medicines (CAPs).</p> <p>In preparation for the UK’s withdrawal from the EU as of 30 March 2019, all medicines for which the UK’s <a href="https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency" style="background-color:rgb(255, 255, 255)">Medicines & Healthcare products Regulatory Agency (MHRA)</a> and <a href="https://www.gov.uk/government/organisations/veterinary-medicines-directorate" style="background-color:rgb(255, 255, 255)">Veterinary Medicines Directorate (VMD)</a> are acting as rapporteurs or co-rapporteurs in centralised procedures will need to be transferred to new rapporteurs and co-rapporteurs from the EU27 Member States, plus Iceland and Norway. The cut-off dates were established based on the average length of a specific procedure, from submission to outcome.</p> <p>For full initial marketing authorisation applications the process is complete and new rapporteurs have been assigned for all CAPs.  </p> <p>For line extensions and extensions of indication, the cut-off dates have already passed and therefore procedures starting after 1 October 2018 will already be taken care of by the new (co)-rapporteurs.</p> <p>All other post-authorisation procedures will be allocated to new (co)-rapporteurs as follows:</p> <ul><li>quality, safety and efficacy type II variations submitted after 26 October 2018;</li> <li>renewal applications submitted after 24 October 2018;</li> <li>periodic safety update reports (CAPS only) submitted after 6 November 2018;</li> <li>type IB variations submitted after 16 January 2019;</li> <li>for veterinary medicines the above cut-off dates apply with the exception of renewals (November 2018) and periodic safety update reports (PSURs) (December 2018).</li> </ul><p>Companies are reminded to submit their applications for any necessary changes allowing their marketing authorisations to remain valid in the EU, Iceland and Norway after Brexit as soon as possible and in consideration of the procedural timelines foreseen in the regulatory framework.</p> <p><strong>Change in format of pre-submission meetings</strong></p> <p>All pre-submission meetings for human and veterinary centralised initial applications requested as of 1 October 2018 will be held remotely (i.e. either via teleconference or virtual meeting) until the Agency is fully operational in its new permanent premises at the end of 2019.</p> <p>No pre-submission meetings for human and veterinary centralised initial applications will take place between 11 February and 15 March 2019, when the Agency’s physical move to its new premises will take place.</p> <p>As of September 2018, pre-submission meetings for scientific advice are only held by teleconference, which has already been the case for most of these meetings since 2017.</p> <div><strong>Note</strong> <hr align="left" size="1" width="33%" /><div id="ftn1"> <ul><li>Pre-submission meetings aim to provide marketing authorisation applicants with information that will assist them in the finalisation of their upcoming marketing authorisation applications.</li> </ul></div> </div> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/update-emas-brexit-preparedness_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Update on EMA’s Brexit preparedness <small class="ema-u-color-grey-2"> (PDF/123.11 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 09/10/2018 <br/> EMA/689345/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 October 2018, , 12/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>CVMP initiates two referral procedures to harmonise consumer safety aspects of veterinary medicines containing paromomycin and tylosin, respectively.</p> <p><strong>CVMP opinions on veterinary medicinal products</strong></p> <p>The European Medicines Agency's (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion for an initial marketing authorisation application for <strong>HorStem</strong>, from EquiCord-Ymas S.L., which was proposed for the treatment of lameness and other clinical symptoms associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.</p> <p>The Committee adopted a negative final opinion for an initial marketing authorisation application for <strong>Longrange </strong><em>(eprinomectin)</em>, from Merial, which was proposed for the treatment and the prevention of reinfections with certain specified parasites in cattle, further to the re-examination of the negative opinion adopted during the Committee meeting held on 19-21 June 2018.</p> <p>More information about the above mentioned medicines will be published on the Agency’s website.</p> <p><strong>Renewals of marketing authorisation</strong></p> <p>The Committee adopted by consensus positive opinions for the renewals of the marketing authorisations for<strong> Bravecto </strong>and<strong> NexGard</strong>. The Committee, having re-assessed the benefit-risk balance of these products, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the renewals of the marketing authorisations. Based on pharmacovigilance grounds the Committee concluded that a further five-year renewal was necessary for Bravecto. An indefinite authorisation was recommended for NexGard.</p> <p><strong>Community referrals and related procedures</strong></p> <p>The Committee started a procedure for <strong>veterinary medicinal products containing paromomycin to be administered parenterally to pigs. </strong>The matter was referred to the Committee by Belgium under Article 35 of Directive 2001/82/EC. This referral procedure concerns the appropriateness of the current indications, posology and withdrawal periods.</p> <p>The Committee started a procedure for <strong>veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep</strong><strong>. </strong>The matter was referred to the Committee by the Netherlands under Article 35 of Directive 2001/82/EC. This referral procedure concerns the appropriateness of the current withdrawal periods (milk, meat and offal) in sheep for the aforementioned veterinary medicinal products.</p> <p><strong>Scientific advice</strong></p> <p>The Committee adopted five scientific advice reports further to requests for:</p> <ul><li>initial advice on safety and efficacy issues for a new antiparasitic veterinary medicinal product for dogs;</li> <li>initial advice on quality, safety and efficacy issues for a new anti-inflammatory veterinary medicinal product for dogs;</li> <li>initial advice on efficacy issues for a new ophthalmic veterinary medicinal product for dogs;</li> <li>follow-up advice on efficacy issues for a new veterinary medicinal product acting on the nervous system in dogs;</li> <li>follow-up advice on quality and efficacy issues for a new immunological veterinary medicinal product for pigs.</li> </ul><p><strong>Minor use, minor species (MUMS)/limited market</strong></p> <p>Following the Committee’s review of a request for classification under the MUMS/limited market policy, the CVMP classified an immunological product for rabbits as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as alternative products for the same indication/species are authorised in the EU.</p> <p>Following the Committee’s review of a request for reclassification under the MUMS/limited market policy, the CVMP reclassified an immunological product for chickens as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as an alternative authorised product already exists for the same indication/species.</p> <p><strong>Pharmacovigilance</strong></p> <p>The Committee reviewed the periodic safety update reports (PSUR) for <strong>Bluevac BTV8, BTVPUR Alsap1, BTVPUR Alsap8</strong>, <strong>Draxxin</strong>, <strong>EQUIP WNVM</strong>, <strong>Meloxivet, Meloxoral</strong>, <strong>Porcilis AR-T-DF</strong>, <strong>Porcilis PCV M Hyo</strong>, <strong>Respiporc FluPan H1N1</strong>, <strong>SevoFlo</strong> and <strong>Suvaxyn Circo MH RTU, </strong>and concluded that no further action or changes to their product information were required.</p> <p>The Committee also reviewed the PSUR for <strong>Bravecto </strong>and recommended amendments to the product literature.</p> <p><strong>Concept papers, guidelines and standard operating procedures (SOP) quality</strong></p> <p>The Committee agreed to extend the consultation period of the draft guideline on the manufacture of veterinary finished dosage form (EMA/CVMP/QWP/798401/2015-Rev.1) until the end of August 2019.</p> <p class="No-numheading1Agency"></p> <p class="No-numheading1Agency"></p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-october-2018_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 October 2018 <small class="ema-u-color-grey-2"> (PDF/87.66 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 12/10/2018 <br/> EMA/CVMP/677247/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU, , 15/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>EU authorities are placing the Chinese company Zheijiang Huahai under increased supervision following European and US inspections which revealed weaknesses in quality management at the company’s Chuannan site in Linhai, China.</p> <p>The inspection findings included deficiencies in the way the company investigated impurities in its valsartan products and led EU authorities to <a href="https://www.ema.europa.eu/en/news/eu-inspection-finds-zhejiang-huahai-site-non-compliant-manufacture-valsartan-ema-national" target="_self">issue a statement of </a><a href="https://www.ema.europa.eu/en/news/eu-inspection-finds-zhejiang-huahai-site-non-compliant-manufacture-valsartan-ema-national">non-compliance with good manufacturing practice (GMP)</a>, prohibiting the use of its valsartan in EU medicines.</p> <p>This latest action means that EU authorities will supervise the manufacture of other active substances produced by Zhejiang Huahai more closely.</p> <p>Authorities will monitor corrective measures being implemented by the company on a regular basis and increase the frequency of inspections of the site. In addition, marketing authorisation holders for EU medicines will be required to perform additional tests on all active substances supplied by Zhejiang Huahai.</p> <p>In July 2018, the detection of impurities – N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) – in valsartan from Zhejiang Huahai led to an <a href="https://www.ema.europa.eu/en/medicines/human/referrals/angiotensin-ii-receptor-antagonists-sartans-containing-tetrazole-group" target="_self">EU-wide review of all valsartan medicines</a>. The review was subsequently <a href="https://www.ema.europa.eu/en/news/valsartan-review-impurities-extended-other-sartan-medicines">extended</a><a href="https://www.ema.europa.eu/en/news/valsartan-review-impurities-extended-other-sartan-medicines" target="_self"> to other ‘sartan’ medicines</a> when very low levels of NDEA were found in losartan made by Hetero Labs in India.</p> <p>Both NDMA and NDEA, which have not been found in any of Zheijiang Huahai’s other products, are classified as probable human carcinogens (substances that could cause cancers). A <a href="https://www.ema.europa.eu/en/news/update-review-valsartan-medicines-risk-ndma-remains-low-related-substance-ndea-also-being" target="_self">preliminary risk assessment for NDMA in valsartan</a> indicated that the lifetime risk of cancer is low.</p> <p><strong>Aurobindo Pharma stopped from supplying irbesartan to the EU</strong></p> <p>Low levels of NDEA have now also been found in a third sartan, irbesartan, made by another Indian company, Aurobindo Pharma. On 8 October 2018, the <a href="https://www.edqm.eu/">European Directorate for the Quality of Medicines & HealthCare (EDQM)</a> suspended Aurobindo Pharma’s CEP<sup><a href="#_ftn1" name="_ftnref1" title="" id="_ftnref1">1</a></sup> effectively stopping the supply in the EU of medicines containing irbesartan from this company.</p> <p>National authorities in the EU are currently considering whether to recall medicines containing Aurobindo Pharma’s irbesartan from pharmacies as a precaution.</p> <p>The review into the presence of impurities in sartans and their potential effects in patients is ongoing. EMA will continue working with national authorities, international partners and EDQM and will provide updates as more information becomes available.</p> <p><strong>More about the medicines</strong></p> <p>The ongoing review is evaluating candesartan, irbesartan, losartan, olmesartan and valsartan, which belong to a class of medicines known as angiotensin-II-receptor antagonists (also known as sartans).</p> <p>The medicines are used to treat patients with hypertension (high blood pressure) and those with heart failure or who have had a recent heart attack. They work by blocking the action of angiotensin II, a hormone that constricts blood vessels and causes blood pressure to rise.</p> <p><strong>More about the procedure</strong></p> <p>The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under <a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000150.jsp&mid=WC0b01ac05800240d0">Article 31 of Directive 2001/83/EC</a>. On 20 September 2018, the review was extended to include medicines containing candesartan, irbesartan, losartan and olmesartan.</p> <p>The review is being carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.</p> <div>  <hr align="left" size="1" width="33%" /><div id="ftn1"> <p><sup><a href="#_ftnref1" name="_ftn1" title="" id="_ftn1">1</a></sup> CEP: <a href="https://www.edqm.eu/en/certificate-suitability-new-applications">certificate of suitability to the monographs of the European Pharmacopoeia</a></p> </div> </div> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/eu-authorities-take-further-action-ongoing-review-sartans_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> EU authorities take further action in ongoing review of sartans <small class="ema-u-color-grey-2"> (PDF/197.83 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 15/10/2018 <br/> EMA/703416/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Sales of antibiotics for use in food-producing animals drop across the EU, , 15/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p> <img alt="ESVAC report" class="file-default media-element" data-delta="2" height="223" src="https://www.ema.europa.eu/sites/default/files/esvac_report_0.png" style="margin: 20px; float: left;" title="ESVAC report" typeof="foaf:Image" width="159" /> A <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/report/sales-veterinary-antimicrobial-agents-30-european-countries-2016-trends-2010-2016-eighth-esvac_en.pdf" target="_blank" type="application/pdf; length=8178365">report published today by the European Medicines Agency (EMA)</a> </span> shows that the overall sales of veterinary antimicrobials across Europe have decreased by more than 20% between 2011 and 2016. This continues the downward trend seen over the last few years and confirms that European Union (EU) guidance and national campaigns promoting prudent use of antibiotics in animals to fight antimicrobial resistance are having a positive effect.</p> <p>A break down per class of antimicrobials shows there was a drop of almost 40% in sales of polymyxins for veterinary use. This class includes colistin, which is used as a last resort treatment in patients with bacterial infections resistant to other antibiotics. Sales of 3rd- and 4th-generation cephalosporins decreased by 15.4%, while sales of quinolones declined by 13.6%.</p> <p>The results are part of EMA’s report of the <a class="ecl-link" href="https://www.ema.europa.eu/en/veterinary-regulatory/overview/antimicrobial-resistance/european-surveillance-veterinary-antimicrobial-consumption-esvac">European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)</a> project, which presents detailed sales data for the year 2016 and records yearly changes in the consumption of veterinary antimicrobials dating back to 2010. For the 8th ESVAC report, 30 countries from the EU and the European Economic Area (EEA) plus Switzerland provided data on sales or prescriptions of veterinary antimicrobials for 2016. Of these, 25 EU Member States submitted data for the entire period between 2011 and 2016. Participation in the ESVAC project has grown substantially, from nine countries initially to 30 today.</p> <p>Reduction in sales is the result of combined efforts of the European Commission, EMA, EU Member States, veterinarians, farmers and other actors in the livestock sector. EU guidance together with national campaigns for prudent use of antibiotics in animals, sales targets and restriction of use of some antimicrobials in food-producing animals are among the actions implemented to reduce the sales of veterinary antimicrobials across Europe under the umbrella of the <a href="https://ec.europa.eu/health/amr/sites/amr/files/amr_action_plan_2017_en.pdf">EU One Health Action Plan against Antimicrobial Resistance</a>. Led by the European Commission, the overarching goal of this plan is to preserve the possibility of effective treatment of infections in humans and animals through a framework for continued, more extensive action to reduce the emergence and spread of AMR.</p> <p>The ESVAC report also shows that the situation across Europe is not homogenous. While 16 of those 25 countries that provided data for 2011-2016 saw a drop in sales of veterinary antimicrobials of 5% or more, six countries recorded an increase of more than 5% in sales during the same period. Given the substantial decline in the sales of antimicrobials for food-producing species observed for some countries, there is also a potential for a decrease of antimicrobial use in other countries, especially in those with a high consumption.</p> <p>The ESVAC project was launched by EMA in April 2010 following a request from the <a href="https://ec.europa.eu/commission/index_en" target="_blank">European Commission</a> to develop a harmonised approach to the collection and reporting of data from EU Member States on the use of antimicrobials in animals. The ESVAC report is issued every year and is used by risk assessors and risk managers in Member States as a reference for antimicrobial policies and for guidance on responsible use of antimicrobials. All data contained in the report are accessible in the <a href="https://esvacbi.ema.europa.eu/analyticsSOAP/saw.dll?PortalPages&PortalPath=/shared/ESVAC%20Public/_portal/Annual%20Report" target="_blank">ESVAC interactive database</a></p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/sales-antibiotics-use-food-producing-animals-drop-across-eu_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Sales of antibiotics for use in food-producing animals drop across the EU <small class="ema-u-color-grey-2"> (PDF/76.67 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 15/10/2018 <br/> EMA/CVMP/683413/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Shaping regulatory science to 2025, , 17/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>EMA is hosting a <a href="https://www.ema.europa.eu/en/events/multistakeholder-workshop-launch-consultation-european-medicines-agency-ema-human-regulatory-science" target="_self">workshop on Wednesday, 24 October</a> to gather insight from stakeholders on the key areas in human medicines to be covered in its ‘Regulatory Science Strategy to 2025’, a proposed new high-level plan for advancing its engagement with regulatory science.</p> <p>The workshop will offer an opportunity to reflect on the scientific and technological advances in the pharmaceutical arena, the challenges that the Agency’s scientific committees and working parties will face in the future and to look at initial proposals to address them. It will also highlight areas relevant to various stakeholder groups in advance of a six-month public consultation on the proposed strategy to be launched in December 2018.</p> <p>“The pace of innovation has accelerated dramatically in recent years and regulators need to be ready to support the development of increasingly complex medicines that more and more deliver healthcare solutions by converging different technologies to promote and protect human and animal health,” said Guido Rasi, EMA’s <a class="ecl-link" href="https://www.ema.europa.eu/en/executive-director">Executive Director</a>. “Also, big data will open up new sources of information on the use of medicines in the real word, and we need to take urgent action to address the challenges arising from collecting and processing this personal data from patients. This will inform the network’s regulatory science strategy and help us to keep on top of developments, identify the gaps between science and healthcare systems and bring together the various stakeholders needed to bridge those gaps.”</p> <p>An <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/agenda/agenda-multistakeholder-workshop-launch-consultation-european-medicines-agency-ema-human-regulatory_en.pdf" target="_blank" type="application/pdf; length=554533">agenda</a> </span> for the workshop is available. Participants will include patients, healthcare professionals and academia, as well as representatives of health technology assessment (HTA) bodies, payer organisations, trade associations and regulators. The workshop will kick off discussions on how to best reshape the regulatory environment so that EMA, working as part of the European medicines regulatory network, can support advances coming through research and development pipelines in the coming years.</p> <p>The workshop can be followed live in the ‘multimedia’ section on the <a href="https://www.ema.europa.eu/en/events/multistakeholder-workshop-launch-consultation-european-medicines-agency-ema-human-regulatory-science" target="_self">event page</a>.</p> <p><strong>Key priorities of the Regulatory Science Strategy to 2025</strong></p> <p>The ‘Regulatory Science Strategy to 2025’ will identify key areas where new or enhanced engagement of the network is essential and where advances in regulatory science will need to be adopted.</p> <p>The strategy will help shape the vision for the next EU Medicines Agencies Network Strategy (2020–2025). It will seek to offer informed guidance on modern product development, facilitate the optimisation of regulatory tools to improve the various processes and critically assess the benefits and risks of innovative therapies and diagnostics based on new technologies.</p> <p>The five key goals of the strategy include:</p> <ul><li>catalysing the integration of science and technology in medicine development;</li> <li>driving collaborative evidence generation -  improving the scientific quality of evaluations;</li> <li>advancing patient-centred access to medicines in partnership with healthcare systems;</li> <li>addressing emerging health threats and availability/therapeutic challenges;</li> <li>enabling and leveraging research and innovation in regulatory science.</li> </ul><p>A workshop to discuss how veterinary medicines will be covered in the regulatory science strategy will take place at EMA on Thursday, 6 December 2018. More details on this workshop will be communicated shortly.</p> <p>The presentations and recordings of both workshops will be published.</p> <p>Participants are encouraged to tweet using the following hashtag: #RegScience2025.</p> <p><strong>Note</strong></p> <ul><li>Regulatory science is defined as the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.</li> </ul></div> </div> </div>


Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018, , 18/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p><a class="ecl-link" href="https://www.ema.europa.eu/en/human-regulatory/overview/fees/pharmacovigilance-fees-payable-european-medicines-agency">Pharmacovigilance fees payable to the European Medicines Agency</a> by applicants and marketing authorisation holders increase by 1.7% as of 18 October 2018, to reflect the inflation rate adjustments of 2017.</p> <p>All applications received by or having a data lock point (DLP) of 17 October 2018 will be charged the current fee and reduction rates. Applications received or having a DLP after that date will be charged the adjusted rates.</p> <p>Further details of the new fee levels are available in the <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R1298&from=EN">Commission Delegated Regulation (EU) No 2018/1298</a> amending Regulation (EU) No 658/2014 and the <span class="file"> <img alt="PDF icon" class="file-icon" src="/modules/file/icons/application-pdf.png" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/other/explanatory-note-pharmacovigilance-fees-payable-european-medicines-agency_en.pdf" target="_blank" type="application/pdf; length=1128577">Explanatory note on fees</a> </span> </p> </div> </div> </div> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="related-content-section" id="related-content-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Related content</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><ul><li><a class="ecl-link" href="https://www.ema.europa.eu/en/human-regulatory/overview/fees/pharmacovigilance-fees-payable-european-medicines-agency">Pharmacovigilance fees payable to the European Medicines Agency</a></li> <li><a class="ecl-link" href="https://www.ema.europa.eu/en/about-us/how-we-work/governance-documents/policies-procedures/pharmacovigilance">Pharmacovigilance</a></li> </ul></div> </div> </div> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="related-documents-section" id="related-documents-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Related documents</h3> </div> </div> </div> </div> <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/other/explanatory-note-pharmacovigilance-fees-payable-european-medicines-agency_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Explanatory note on pharmacovigilance fees payable to the European Medicines Agency <small class="ema-u-color-grey-2"> (PDF/1.08 MB) </small> <small class="ema-u-color-epar-red"> (updated)</small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 10/03/2015 <br/> Last updated: 18/10/2018 <br/> European Medicines Agency </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin , , 19/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency has recommended granting a marketing authorisation for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.</p> <p>HAE is a long-term debilitating disease characterised by attacks of swelling beneath the skin that can occur anywhere in the body, such as in the face, limbs, gut and larynx. It is caused by abnormalities in the gene responsible for the production of C1 esterase inhibitor. This results in low C protein levels in the blood which induce increased kallikrein protein activity and ultimately cause the swelling. When the swelling occurs in the larynx it may be life-threatening as it can obstruct the airways and impede breathing.</p> <p>Takhzyro is the first monoclonal antibody for the prevention of this disease. It has been designed to recognise and attach to kallikrein proteins, and thereby block the activity of the kallikrein-kinin system and reduce the number of angioedema attacks. Takhzyro is administered subcutaneously every 2-4 weeks, offering an improvement in patient care compared to current alternative therapies which are administered  either intravenously or more frequently via subcutaneous route. Therefore, the Committee for Medicinal Products for Human Use (CHMP) considered that Takhzyro was of major interest for public health and agreed to the applicant’s request for an accelerated assessment of this medicine.</p> <p>The benefits and safety of Takhzyro were studied in a phase 3 clinical study involving 125 patients. During 26 weeks of treatment, patients who received Takhzyro showed a significant reduction in the total HAE attack rate and severity. The most common adverse reactions were injection site reactions of mild intensity.</p> <p>Because HAE is a very rare disease which is estimated to affect less than 0.5 in 10,000 people in the EU, Takhzyro was granted an orphan designation in October 2015. As always at time of approval, this orphan designation will now be reviewed by EMA’s Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining Takhzyro’s orphan status and granting this medicine ten years of market exclusivity.</p> <p>The opinion adopted by the CHMP is an intermediary step on Takhzyro's path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once the marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.</p> <hr /><p><strong>Note: </strong></p> <ul><li>The applicant for Takhzyro is Shire Pharmaceuticals Ireland Limited.</li> </ul></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/new-medicine-hereditary-angioedema-rare-disease-causing-swelling-beneath-skin_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin <small class="ema-u-color-grey-2"> (PDF/75.1 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 19/10/2018 <br/> EMA/CHMP/721397/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


First treatment for rare inherited muscle contraction disorders, , 19/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency has recommended granting a marketing authorisation for Namuscla (mexiletine hydrochloride) for the treatment of adult patients with non-dystrophic myotonia, a group of inherited muscle disorders where muscles are slow to relax after contraction. These disorders are chronic life-long debilitating conditions characterised by pain, fatigue, and muscle stiffness, resulting in frequent falls and disability.</p> <p style="margin-left:.1pt">This is the first time that a treatment for certain forms of myotonic disorders could be authorised EU-wide. The active substance mexiletine has been approved for treatment of these disorders in France only since 2010. Non-dystrophic myotonia is caused by abnormalities in the ion channels, tiny pores in the muscle cells that control the passage of charged particles (ions) such as sodium or chloride and play a key role in the contraction and relaxation of muscles.</p> <p style="margin-left:.1pt">Mexiletine is a known antiarrhythmic medicine (used to restore normal heart rhythm), which was first authorised in Europe in the 1970s. It works by blocking ion channels for sodium ions in muscle cells. These sodium channels play a role in the contraction and relaxation of muscles and by blocking them, the medicine helps to reduce the rate of contractions as well as the stiffness that occurs when the contractions are prolonged.</p> <p>The opinion from the Committee for Medicinal Products for Human Use (CHMP) is based on data from one phase 3 clinical trial in patients with non-dystrophic myotonia as well as data from the literature. These data show that treatment with mexiletine allows relieving stiffness in the muscles. The medicine’s safety profile is well-established; the most common unfavourable effects with this medicine were gastrointestinal disorders, such as heartburn, nausea, vomiting, diarrhoea and abdominal pain. Another less frequently occurring side effect of mexiletine is that it can also trigger arrhythmia or aggravate an existing arrhythmia; the CHMP therefore agreed on specific measures to minimise this risk such as certain contraindications and cardiac monitoring.</p> <p>Namuscla was designated as an orphan medicinal product in November 2014. As always at time of approval, EMA's Committee for Orphan Medicinal Products (COMP) will review the orphan designation to determine whether the information available to date allows maintaining Namuscla’s orphan status.</p> <p>The opinion adopted by the CHMP is an intermediary step on Namuscla’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.</p> <hr /><p><strong>Note:</strong></p> <ul><li>The applicant for Namuscla is Lupin Europe GmbH.</li> </ul></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/first-treatment-rare-inherited-muscle-contraction-disorders_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> First treatment for rare inherited muscle contraction disorders <small class="ema-u-color-grey-2"> (PDF/74.91 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 19/10/2018 <br/> EMA/CHMP/716161/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018, , 19/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The CHMP recommended six medicines for approval, three extensions of indications and elected its new vice-chair at its October 2018 meeting.</p> <p><strong>Six medicines recommended for approval, including two orphan medicines</strong><sup>1</sup></p> <p>The CHMP recommended granting a marketing authorisation for <strong>Takhzyro</strong> (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE). This medicine was reviewed under EMA's accelerated assessment procedure, reserved for medicines of major public health interest. For more information, please see the press release in the grid below.</p> <p>The Committee recommended granting a marketing authorisation for <strong>Namuscla</strong> (mexiletine hydrochloride), for the treatment of myotonia in adult patients with non-dystrophic myotonic disorders. This is the first treatment for this disease to be authorised EU-wide. For more information, please see the press release in the grid below.</p> <p>The CHMP recommended granting a marketing authorisation for <strong>Dengvaxia</strong> (dengue tetravalent vaccine (live, attenuated)), the first vaccine in the EU for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection. For more information, please see the press release in the grid below.</p> <p>The Committee adopted a positive opinion for <strong>Flucelvax Tetra</strong> (influenza vaccine surface antigen inactivated prepared in cell cultures), intended for the prevention of influenza in adults and children from 9 years of age.</p> <p>The CHMP also recommended the granting of a marketing authorisation for <strong>Bevespi Aerosphere</strong> (glycopyrronium / formoterol fumarate dihydrate), for maintenance treatment of chronic obstructive pulmonary disease (COPD).</p> <p>The biosimilar medicine <strong>Ogivri</strong> (trastuzumab) received a positive opinion from the CHMP for the treatment of breast and gastric cancer.</p> <p><strong>Three recommendations on extensions of therapeutic indication</strong></p> <p>The Committee recommended extensions of indication for <strong>Kalydeco</strong>, <strong>Keytruda</strong> and <strong>NovoSeven</strong>.</p> <p><strong>CHMP elects new vice-chair</strong></p> <p>The Committee elected Professor Bruno Sepodes from Portugal as its new vice-chair, for a three-year mandate, starting on 15 October 2018. Professor Sepodes replaces Dr Harald Enzmann, who was elected as CHMP Chair at the September 2018 CHMP meeting. Bruno Sepodes is a member of the evaluation board of medicines at the Portuguese national competent authority - the National Authority for Medicines and Health Products (INFARMED). He has been a member of the CHMP since 2012. In parallel to his involvement in the CHMP, he was also the Chair of EMA’s Committee for Orphan Medicinal Products (COMP) from 2012 to 2018.</p> <p><strong>Agenda and minutes</strong></p> <p>The agenda of the October 2018 meeting is published on EMA's website. Minutes of the September 2018 CHMP meeting will be published in the coming weeks.</p> <p><strong>CHMP statistics</strong></p> <p>Key figures from the September 2018 CHMP meeting are represented in the graphic below.</p> <hr /><div> <p><sup>1</sup>As always at time of approval, these orphan designations will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicines' orphan status and granting the medicines ten years of market exclusivity.</p> <p><img alt=" October 2018" data-delta="4" data-fid="194015" data-media-element="1" src="https://www.ema.europa.eu/sites/default/files/chmp_highlights_october_2018.png" title="" typeof="Image" /></p> </div> </div> </div> </div> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="positive-recommendations-on-new-medicines-section" id="positive-recommendations-on-new-medicines-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Positive recommendations on new medicines</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Name of medicine</th> <th scope="col">Bevespi Aerosphere </th> </tr></thead><tbody><tr><td>International non-proprietary name (INN)</td> <td>glycopyrronium / formoterol fumarate dihydrate</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>AstraZeneca AB</td> </tr><tr><td>Therapeutic indication</td> <td> <p>Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)</p> </td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-bevespi-aerosphere_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP summary of positive opinion for Bevespi Aerosphere <small class="ema-u-color-grey-2"> (PDF/61.56 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 19/10/2018 <br/> EMA/CHMP/70534/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Name of medicine</th> <th scope="col">Dengvaxia</th> </tr></thead><tbody><tr><td>Common name</td> <td>dengue tetravalent vaccine (live, attenuated)</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Sanofi Pasteur</td> </tr><tr><td>Therapeutic indication</td> <td>For the prevention of dengue caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection.</td> </tr><tr><td>More information</td> <td><a href="https://www.ema.europa.eu/en/news/first-vaccine-prevention-dengue">First vaccine for prevention of dengue</a></td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-dengvaxia_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP summary of positive opinion for Dengvaxia <small class="ema-u-color-grey-2"> (PDF/103.6 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 19/10/2018 <br/> EMA/CHMP/666423/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Name of medicine</th> <th scope="col">Flucelvax Tetra </th> </tr></thead><tbody><tr><td>Common name</td> <td>influenza vaccine surface antigen inactivated prepared in cell cultures</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Seqirus Netherlands B.V.</td> </tr><tr><td>Therapeutic indication</td> <td> <p>Prophylaxis of influenza in adults and children from 9<strong> </strong>years of age. </p> </td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-flucelvax-tetra_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP summary of positive opinion for Flucelvax Tetra <small class="ema-u-color-grey-2"> (PDF/69.4 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 19/10/2018 <br/> EMA/CHMP/641495/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Name of medicine</th> <th scope="col">Namuscla</th> </tr></thead><tbody><tr><td>INN</td> <td>mexiletine hcl</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Lupin Europe GmbH</td> </tr><tr><td>Therapeutic indication</td> <td>Symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders</td> </tr><tr><td>More information</td> <td><a href="https://www.ema.europa.eu/en/news/first-treatment-rare-inherited-muscle-contraction-disorders">First treatment for rare inherited muscle contraction disorders</a></td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-namuscla_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP summary of positive opinion for Namuscla <small class="ema-u-color-grey-2"> (PDF/68.51 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 19/10/2018 <br/> EMA/CHMP/650838/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Name of medicine</th> <th scope="col">Ogivri</th> </tr></thead><tbody><tr><td>INN</td> <td>trastuzumab</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>MYLAN S.A.S</td> </tr><tr><td>Therapeutic indication</td> <td> <p>Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC)</p> </td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-ogivri_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP summary of positive opinion for Ogivri <small class="ema-u-color-grey-2"> (PDF/79.24 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 19/10/2018 <br/> EMA/CHMP/688548/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Name of medicine</th> <th scope="col">Takhzyro</th> </tr></thead><tbody><tr><td>INN</td> <td>lanadelumab </td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Shire Pharmaceuticals Ireland Limited</td> </tr><tr><td>Therapeutic indication</td> <td> <p>Treatment of angioedema attacks, prevention of angioedema attacks</p> </td> </tr><tr><td>More information</td> <td><a href="https://www.ema.europa.eu/en/news/new-medicine-hereditary-angioedema-rare-disease-causing-swelling-beneath-skin">New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin</a></td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-takhzyro_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP summary of positive opinion for Takhzyro <small class="ema-u-color-grey-2"> (PDF/71.66 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 19/10/2018 <br/> EMA/700432/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="positive-recommendations-on-extensions-of-therapeutic-indications-section" id="positive-recommendations-on-extensions-of-therapeutic-indications-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Positive recommendations on extensions of therapeutic indications</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Name of medicine</th> <th scope="col">Kalydeco</th> </tr></thead><tbody><tr><td>INN</td> <td>ivacaftor</td> </tr><tr><td>Marketing-authorisation applicant</td> <td> <p>Vertex Pharmaceuticals (Europe) Ltd</p> </td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-kalydeco-ii-69_en-0.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP post-authorisation summary of positive opinion for Kalydeco (II-69) <small class="ema-u-color-grey-2"> (PDF/67.47 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 19/10/2018 <br/> EMA/CHMP/727925/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Name of medicine</th> <th scope="col">Keytruda</th> </tr></thead><tbody><tr><td>INN</td> <td>pembrolizumab</td> </tr><tr><td>Marketing-authorisation applicant</td> <td> <p>Merck Sharp & Dohme B.V.</p> </td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-keytruda-ii-47_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP post-authorisation summary of positive opinion for Keytruda (II-47) <small class="ema-u-color-grey-2"> (PDF/94.37 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 19/10/2018 <br/> EMA/CHMP/706955/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Name of medicine</th> <th scope="col">NovoSeven </th> </tr></thead><tbody><tr><td>INN</td> <td>eptacog alfa (activated)</td> </tr><tr><td>Marketing-authorisation applicant</td> <td> <p>Novo Nordisk A/S</p> </td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-novoseven_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP post-authorisation summary of positive opinion for NovoSeven <small class="ema-u-color-grey-2"> (PDF/72.28 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 19/10/2018 <br/> EMA/CHMP/701490/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="outcomes-of-arbitration-procedures-section" id="outcomes-of-arbitration-procedures-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Outcomes of arbitration procedures</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Name of medicine</th> <th scope="col">Paclitaxel Hetero </th> </tr></thead><tbody><tr><td>INN</td> <td> <div> </div> <div>paclitaxel, 6 mg/ml concentrate for solution for infusion</div> </td> </tr><tr><td>Marketing-authorisation applicant</td> <td> <p>Hetero Europe S.L.</p> </td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/referral/paclitaxel-hetero-article-294-referral-ema-recommends-refusal-authorisation-paclitaxel-hetero/ml-concentrate-solution-infusion_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Paclitaxel Hetero Article 29(4) referral - EMA recommends refusal of authorisation for Paclitaxel Hetero (paclitaxel, 6 mg/ml concentrate for solution for infusion) <small class="ema-u-color-grey-2"> (PDF/69.58 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 19/10/2018 <br/> EMA/712446/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col">Name of medicine</th> <th scope="col">Perlinring 0.120mg/0.015mg per 24 hours Vaginal Delivery System</th> </tr></thead><tbody><tr><td>INN</td> <td>etonogestrel and ethinylestradiol</td> </tr><tr><td>Marketing-authorisation applicant</td> <td> <p>Actavis Group PTC EHF</p> </td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel/ethinylestradiol-vaginal-ring-eu_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Perlinring Article-29(4) referral - EMA recommends authorisation of Perlinring (etonogestrel / ethinylestradiol vaginal ring) in the EU <small class="ema-u-color-grey-2"> (PDF/78.43 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 19/10/2018 <br/> EMA/720896/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="other-updates-section" id="other-updates-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Other updates</h3> </div> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/chmp-annex/overview-invented-names-reviewed-september-2018-name-review-group-nrg_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Overview of (invented) names reviewed in September 2018 by the Name Review Group (NRG) <small class="ema-u-color-grey-2"> (PDF/144.34 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 19/10/2018 <br/> EMA/727739/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/chmp-annex/start-community-reviews-chmp-meeting-15-18-october-2018_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Start of community reviews - CHMP meeting of 15-18 October 2018 <small class="ema-u-color-grey-2"> (PDF/60.12 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 19/10/2018 <br/> EMA/712987/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="related-content-section" id="related-content-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Related content</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><ul><li> <div><a href="https://www.ema.europa.eu/en/news/new-medicine-hereditary-angioedema-rare-disease-causing-swelling-beneath-skin">New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin</a> (19/10/2018)</div> </li> <li> <div><a href="https://www.ema.europa.eu/en/news/first-treatment-rare-inherited-muscle-contraction-disorders">First treatment for rare inherited muscle contraction disorders</a> (19/10/2018)</div> </li> <li> <div><a href="https://www.ema.europa.eu/en/news/first-vaccine-prevention-dengue">First vaccine for prevention of dengue</a> (19/10/2018)</div> </li> <li> <div><a href="https://www.ema.europa.eu/en/events/committee-medicinal-products-human-use-chmp-15-18-october-2018">Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018</a></div> </li> <li><a href="https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights">CHMP: Agendas, minutes and highlights</a></li> </ul><p>Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.</p> </div> </div> </div> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="contact-point-section" id="contact-point-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Contact point</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p><strong>EMA Press office</strong><br /> Tel. +44 (0)20 3660 8427<br /> E-mail: <a href="mailto:press@ema.europa.eu">press@ema.europa.eu</a><br /> Follow us on Twitter <a href="https://twitter.com/EMA_News" target="_blank">@EMA_News</a></p> </div> </div> </div>


First vaccine for prevention of dengue, , 19/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Dengvaxia (dengue tetravalent vaccine (live, attenuated)), for the prevention of dengue caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection.</p> <p>Dengue is caused by a virus which is transmitted by <em>Aedes</em> mosquitoes, a type of mosquito that is widely spread in tropical and subtropical regions. Most people who contract the disease experience mild, flu-like symptoms. However, around two percent of people affected will develop severe dengue, a potentially lethal complication that includes dengue haemorrhagic fever and/or dengue shock syndrome. Main risk factors for severe dengue include young age and chronic diseases. Secondary infection, in the form of two sequential infections by different serotypes, is also a risk factor for severe disease.</p> <p>There are four types of dengue virus and people living in a dengue-endemic area can have several dengue infections in their lifetime. No specific treatments for dengue exist and prevention is mainly limited to the environmental management of mosquitoes. There is currently no vaccine available for dengue in the EU.</p> <p>Dengue is by far the most common mosquito-borne viral disease affecting people worldwide (mainly in tropical areas); tens of millions of cases occur each year resulting in approximately 20,000-25,000 deaths, mainly in children<sup>1</sup>.</p> <p>The approved indication excludes the populations of the EU mainland and territories outside tropical areas since dengue is not endemic in these regions. However, a number of EU territories, mainly overseas, are situated in endemic areas, and these territories could benefit from this vaccine.</p> <p>The benefits and safety of Dengvaxia have been evaluated in 31 clinical studies conducted mostly in dengue endemic areas (Latin America and Asia Pacific). Together, these trials included over 41,000 participants aged 9 months to 60 years receiving at least one dose of the vaccine. The overall available data demonstrate that for people between 9 and 45 years of age, the vaccine has positive effects in preventing symptomatic and severe dengue disease in people who have had previous dengue infection and live in endemic areas. In people who have never had dengue, there is an increased risk of clinically severe dengue disease leading to hospitalisation when vaccinees are subsequently infected with dengue virus. The CHMP therefore recommends limiting the use of the vaccine to individuals with prior dengue virus infection, for whom laboratory confirmation of the previous infection is available before vaccination. In addition, because there are no safety, immunogenicity or efficacy data to support vaccination of individuals living in non-endemic areas and travelling to endemic areas, vaccination of these individuals is not recommended.</p> <p>A number of additional risk minimisation measures will be put in place, such as educational material for physicians and a guide for healthcare professionals. Use of the vaccine should be according to official recommendation from Member States.</p> <p>The opinion adopted by the CHMP is an intermediary step on Dengvaxia’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.</p> <hr /><p><strong>Note</strong></p> <p>The applicant for Dengvaxia is Sanofi Pasteur.</p> <p><sup>1</sup><a href="https://ecdc.europa.eu/en/dengue-fever/facts/factsheet">https://ecdc.europa.eu/en/dengue-fever/facts/factsheet</a></p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/first-vaccine-prevention-dengue_en-0.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> First vaccine for prevention of dengue <small class="ema-u-color-grey-2"> (PDF/72.14 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 19/10/2018 <br/> EMA/CHMP/717080/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="contact-point-section" id="contact-point-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Contact point</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p class="BodytextAgency"><strong>EMA press office</strong><br /> Tel. +44 (0)20 3660 8427<br /> E-mail: <a href="mailto:press@ema.europa.eu">press@ema.europa.eu</a><br /> Follow us on Twitter <a href="http://www.twitter.com/EMA_News">@EMA_News</a></p> </div> </div> </div>


Regulatory update - EMA encourages companies to submit type I variations for 2018 by end of November 2018, , 26/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA<sub>IN</sub> and type IA variations for 2018 no later than Friday 30 November 2018. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 21 December 2018 and 2 January 2019 and within the 30-day timeframe set out in Article 14 of <a href="http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:334:0007:0024:en:PDF" target="_blank">Commission Regulation (EC) No 1234/2008</a>.</p> <p>Marketing authorisation holders planning to report Brexit-related Type IA/IA<sub>IN</sub> variations in December 2018 will receive the acknowledgment of the validity of the submissions within 30 days as per the usual procedure.</p> <p>Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 7 December 2018 for a start of procedure in 2018. For submissions received on or after 10 December 2018, the procedure may not start until January 2019.</p> <p>For procedural or regulatory queries related to these procedures for human medicines, marketing authorisation holders can send an email to: <a href="mailto:IAquery@ema.europa.eu">iaquery@ema.europa.eu</a> or <a href="mailto:IBquery@ema.europa.eu">ibquery@ema.europa.eu</a>. For veterinary medicines, the following e-mail address should be used: <a href="mailto:vet.applications@ema.europa.eu">vet.applications@ema.europa.eu</a>.</p> <p>Type I variations are minor changes to the marketing authorisation of a medicine.</p> <p>Type IA<sub>IN</sub> and IA variations have no impact on the quality, safety or efficacy of the medicine. Type IA<sub>IN</sub> variations must be notified to the national competent authority or EMA immediately following implementation, in order to ensure the continuous supervision of the medicine. Type IA variations do not require immediate notification and should be notified to the national competent authority or the EMA within 12 months of implementation, or earlier in certain cases.</p> <p>Type IB variations must be notified to the national competent authority or the EMA before implementation, but do not require a formal approval. Upon acknowledgement of receipt of a valid notification, the marketing authorisation holder must wait for a period of 30 days to ensure that the notification is deemed acceptable by the national competent authority or EMA before implementing the change.</p> </div> </div> </div>


EMA experts awarded for excellence in standards development, , 26/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>Five EMA staff members – Paolo Alcini, Sabine Brosch, Tim Buxton, Ilaria Del Seppia and Panagiotis Telonis – have won an <a href="https://www.iso.org/iso-awards.html#excellence-anchor">ISO Excellence Award</a> for their achievements in the development of international standards for the identification of medicinal products (IDMP). The award was presented by Michael Glickman, chair of the <a href="https://www.iso.org/home.html">International Organization for Standardization (ISO)</a> Technical Committee for Health Informatics at the ISO plenary meeting on 22 October 2018 in Paestum, Italy.</p> <p>These standards facilitate the exchange of information about medicines between regulators, worldwide data sources and pharmaceutical companies. They provide the basis for the unambiguous identification of medicines worldwide, which will strengthen regulatory activities and in particular improve the continuous monitoring of the medicines’ safety after they have entered the market.</p> <p> “I congratulate my colleagues for their invaluable work and major contribution to global standardisation,” said Guido Rasi, EMA’s <a href="https://www.ema.europa.eu/en/questions-and-answers/deputy-executive-director" target="_self">Executive Director</a>. “Internationally accepted IDMP standards enable the efficient exchange of information on medicines and will improve pharmacovigilance and safety monitoring that we carry out to ensure patient safety.”</p> <p>Research, development and production of medicines are global. However, regulatory requirements applying to medicines are fragmented as they are developed by various national regulators, resulting in different processes and operating models. This is further complicated by the use of multiple languages, different terminologies and data models, as well as different technical standards for information exchange.</p> <p>EMA’s team was supported in their efforts by other EMA staff and experts from across the EU. They were part of a global collaborative effort led by ISO, involving medical experts from 32 participating and 27 observing countries who developed a set of five international IDMP standards. These standards provide common formats, data structures, quality criteria and terminologies to identify medicines and exchange information between worldwide regulators and healthcare communities. ISO IDMP covers the entire product lifecycle: medicines in development, medicines under evaluation and authorised products.</p> <p>EMA is implementing the ISO IDMP standards in phases through its <a href="https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/substance-product-organisation-referential-spor-master-data">SPOR programme</a>. With SPOR, EMA is delivering a set of master data management services for pharmaceutical and regulatory data relating to substances, products, organisations and referentials (SPOR) to enable consistent reuse in EMA’s multiple business cases.</p> <p>Referential and organisation services were delivered and are already used in regulatory applications and business processes, such as electronic application forms (eAF), the <a href="https://iris.ema.europa.eu/">orphan medicines application portal (IRIS)</a> or the EudraVigilance (EV) user registration process. This is followed by the iterative implementation of products and substance data services.</p> </div> </div> </div>


EMA closed 1-2 November 2018, , 30/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>EMA is closed from 18:30 on Wednesday 31 October until 7:30 on Monday 5 November 2018.</p> <p>Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +44 (0)20 3660 7600. Please note that this is an emergency number and should only be used in the event of a potentially serious problem with a centrally authorised product.</p> </div> </div> </div>


Working with stakeholders to improve availability of medicines in the EU, , 31/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>The <a href="http://www.hma.eu/522.html" target="_blank">task force set up by EMA and the Heads of Medicines Agencies (HMA) on availability of authorised human and veterinary medicines</a> is organising a two-day workshop (8-9 November 2018) at EMA in London to gather stakeholders' perspectives on how to better address potential problems with the supply of medicines and how to avoid <a href="https://www.ema.europa.eu/en/human-regulatory/post-authorisation/medicine-shortages" target="_self">shortages of medicines</a>.</p> <p>Improving the availability of human and veterinary medicines authorised in the EU is a key priority of the <a class="ecl-link" href="https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network">European medicines regulatory network</a>. The aim of the task force is to develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect availability of medicines, in order to improve continuity of supply of human and veterinary medicines across Europe. In the context of the potential supply disruption of medicines following the <a href="https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit" target="_self">UK’s withdrawal from the EU</a>, the task force serves as a platform to facilitate and coordinate actions between Member States, EMA and the European Commission.</p> <p>The <a href="https://www.ema.europa.eu/en/work-programme/work-programme-hmaema-task-force-availability-authorised-medicines-human-veterinary-use" target="_self">task force’s work programme for the coming two years</a> was published in August 2018.</p> <p><a href="https://www.ema.europa.eu/en/events/heads-medicines-agencies-european-medicines-agency-technical-meeting-availability-authorised-human" target="_self">Day 1 of the workshop</a> is a technical meeting with industry stakeholders to focus on the pharmaceutical industry’s critical role in the prevention and management of medicine shortages. Industry stakeholders are invited to give their feedback on the technical implications of some of the actions set out in the work plan of the task force in the field of human medicines and to present best practices already developed for the prevention of shortages.</p> <p><a href="https://www.ema.europa.eu/en/events/multi-stakeholder-workshop-heads-medicines-agencies-european-medicine-agency-task-force-availability" target="_self">Day 2 of the workshop</a> will bring together regulators, industry representatives, healthcare professionals, patients and consumers, academia and NGOs. The purpose of this second day is to obtain the views of all stakeholders on the work of the task force and to discuss how the different stakeholder groups can contribute to the actions in the workplan. The workshop will mainly focus on human medicines; however, issues common to both human and veterinary medicines will be addressed in the context of Brexit.</p> <p>The workshop is by invitation only, but day 2 will be broadcast live on EMA’s website. Agendas for both days are available.</p> <p>The task force consists of representatives from EMA, the <a href="https://ec.europa.eu/commission/index_en">European Commission</a> and national competent authorities, the chairs of the Co-ordination Groups for Mutual Recognition and Decentralised Procedures – Human (CMDh) and Veterinary (CMDv), the <a class="ecl-link" href="https://www.ema.europa.eu/en/gmpgdp-inspections-working-party">GMP/GDP Inspections Working Party</a>, the <a href="http://www.hma.eu/wgcp.html">HMA Working Group of Communication Professionals (WGCP)</a> and the <a href="http://www.hma.eu/esswg.html">European Surveillance Strategy Working Group (ESS WG</a>).</p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/working-stakeholders-improve-availability-medicines-eu_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Working with stakeholders to improve availability of medicines in the EU <small class="ema-u-color-grey-2"> (PDF/46.58 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 30/10/2018 <br/> EMA/720894/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Meeting highlights from EMA’s safety committee (PRAC) 29-31 October 2018, , 31/10/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of signals, risk management plans, periodic safety update reports and post-authorisation safety studies.</p> <p>The Committee did not start or conclude any referral procedures. More information on all safety reviews currently under evaluation is provided in the ‘Ongoing referrals’ table.</p> <p>Information on all topics discussed by the PRAC is available in the agenda below. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting at the end of November.</p> </div> </div> </div> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="agenda-section" id="agenda-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Agenda</h3> </div> </div> </div> </div> <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/agenda/agenda-prac-draft-agenda-meeting-29-31-october-2018_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Agenda - PRAC draft agenda of meeting 29-31 October 2018 <small class="ema-u-color-grey-2"> (PDF/578.13 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Draft<br/> <br /> First published: 29/10/2018 <br/> EMA/PRAC/765002/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="ongoing-referrals-section" id="ongoing-referrals-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Ongoing referrals</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="1" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="background-color:rgb(227, 227, 227)"> <p>Procedure</p> </th> <th style="background-color:rgb(227, 227, 227)"> <p>Status</p> </th> <th style="background-color:rgb(227, 227, 227)"> <p>Update</p> </th> </tr></thead><tbody><tr><td style="background-color:rgb(255, 255, 255)"> <p>Article-31 procedure: <a class="ecl-link" href="https://www.ema.europa.eu/en/medicines/human/referrals/methotrexate-containing-medicinal-products">Methotrexate containing medicinal products</a></p> </td> <td style="background-color:rgb(255, 255, 255)"> <p>Under evaluation</p> </td> <td style="background-color:rgb(255, 255, 255)"> <p>PRAC continued assessment.</p> </td> </tr></tbody></table></div> </div> </div>


Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 November 2018, , 09/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><h4>CVMP opinions on veterinary medicinal products</h4> <p>The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for <strong>Isemid</strong> (torasemide), from CEVA Santé Animale, a new cardiovascular product intended for treatment of clinical signs related to congestive heart failure in dogs, including pulmonary oedema.</p> <p>The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for <strong>Syvazul BTV</strong>, from LABORATORIOS SYVA, S.A.U., a vaccine for the active immunisation of sheep to prevent viraemia and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/or 8, and/or to reduce viraemia and clinical signs caused by bluetongue virus serotype 4; and of cattle to prevent viraemia caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia caused by bluetongue virus serotype 4.</p> <p>The Committee adopted by consensus a positive opinion for a type II variation application for <strong>Aftovaxpur DOE </strong>concerning a change to the onset of immunity in cattle and sheep.</p> <p>More information about the above mentioned medicines, including their full indications, will be published on the Agency’s website.</p> <h4>Renewals of marketing authorisation</h4> <p>The Committee adopted by consensus positive opinions for the renewal of the marketing authorisations for <strong>Loxicom</strong> and <strong>Parvoduk</strong>. The Committee, having re-assessed the benefit-risk balance of these products, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the renewals of the marketing authorisations. Based on pharmacovigilance grounds (limited data) the Committee concluded that a further 5-year renewal was necessary for Parvoduk. An indefinite authorisation was recommended for Loxicom.</p> <h4>Community referrals and related procedures</h4> <p>The Committee concluded a procedure concerning the need for inclusion of a maximum limit for histamine in the active substance and/or finished product specifications for <strong>veterinary medicinal products containing gentamicin for parenteral administration to horses</strong>. The procedure responds to a request from the European Medicines Agency Executive Director for the Committee to give a scientific opinion under Article 30(3) of Regulation 726/2004 in connection with adverse reactions seen in horses following use of gentamicin solution for injection. The adverse reactions were considered to be linked to histamine residues present in the active substance. The Committee adopted by consensus an opinion concluding that, where relevant, a maximum limit for histamine should be included in the specification for the active substance gentamicin. In addition, the Committee has made recommendations to the European Directorate for the Quality of Medicines (EDQM), active substance manufacturers and marketing authorisation holders.</p> <p>The opinion and assessment report will be published on the Agency’s website.</p> <p>Scientific advice</p> <p>The Committee adopted two scientific advice reports further to requests for:</p> <ul><li>initial advice on quality, safety and efficacy issues for a new immunological veterinary medicinal product for dogs;</li> <li>initial advice on safety and efficacy issues for a new immunological veterinary medicinal product for chickens.</li> </ul><h4>Minor use, minor species (MUMS)/limited market</h4> <p>Following the Committee’s review of a request for classification under the MUMS/limited market policy, the CVMP classified an indication in a veterinary medicinal product (antiparasitics, insecticides and repellents) for cats as indicated for MUMS/limited market and eligible for reduced data requirements. The product is not eligible for financial incentives as it is intended for use in non-food producing species.</p> <p>Following the Committee’s review of a request for reclassification under the MUMS/limited market policy, the CVMP reclassified an immunological product for foxes and raccoon dogs as intended for a MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives.</p> <h4>Pharmacovigilance</h4> <p>The Committee reviewed the PSURs for <strong>Acticam</strong>, <strong>EQUIOXX</strong>, <strong>Fevaxyn Pentofel</strong>, <strong>Halagon</strong>, <strong>Rabitec</strong>,<strong> Trifexis</strong>,<strong> Velactis</strong>, <strong>Versican Plus DHPPI L4 and </strong><strong>Versican Plus DHPPi L4R</strong> and concluded that no changes to their product information or other regulatory action were required.</p> <p>The Committee also reviewed the PSURs for <strong>MiPet Easecto, </strong><strong>Simparica </strong>and <strong>Zycortal</strong> and recommended amendments to the product information.</p> <h4>Concept papers, guidelines and SOPs</h4> <p><strong>Quality </strong></p> <p>The Committee adopted a draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (EMA/CVMP/QWP/153641/2018) for public consultation until 31 August 2019. This new reflection paper has been developed to address the requirements to control elemental impurities in veterinary medicinal products, as a result of updates in the European Pharmacopoeia General Monograph 2619 for pharmaceutical preparations. The Committee also adopted revised timelines for the implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products (EMA/CVMP/QWP/631010/2017).</p> <p>Both the draft reflection paper and the timelines for implementation document will be published on the Agency’s website.</p> <p>The Committee adopted the revised guideline on active substance master file procedure (EMEA/CVMP/134/02 Rev 4). The update is intended to clarify the responsibilities of the applicant/marketing authorisation holder in the provision of information related to active substances.</p> <p>The revised guideline will be published on the Agency’s website.</p> <p>The Committee adopted a question and answer on requirements for selection and justification of starting materials for the manufacture of chemical active substances in veterinary medicinal products.</p> <p>The question and answer will be published on the Agency’s website.</p> <p><strong>Environmental Risk Assessment </strong></p> <p>The Committee adopted a draft reflection paper (EMA/CVMP/ERA/632109/2014) on antimicrobial resistance in the environment for a nine-month period of public consultation. This draft reflection paper has examined key sources and pathways relevant to the release of antimicrobials in the environment from the use of antimicrobial veterinary medicinal products, including the potential transport of antimicrobial resistance genes. The paper considers the suitability of the current environmental risk assessment for characterising the potential risks posed by antimicrobial resistance genes, and concludes in a series of recommendations to improve the understanding of the impact to animal and human health of antimicrobials in the environment resulting from the use of veterinary medicinal products.</p> <p>The document will be published on the Agency’s website.</p> <p><strong>Antimicrobials</strong></p> <p>The Committee adopted a reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union (EMA/CVMP/AWP/237294/2017). The reflection paper aims to explore the potential risks related to antimicrobial resistance associated with the use of antimicrobial in veterinary medicine which does not comply with the approved summary of product characteristics.</p> <p>The reflection paper together with the overview of comments (EMA/CVMP/EWP/30098/2018) will be published on the Agency’s website.</p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-november-2018_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 November 2018 <small class="ema-u-color-grey-2"> (PDF/85.58 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 09/11/2018 <br/> EMA/CVMP/741346/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision, , 13/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>A <span class="file"> <img alt="PDF icon" class="file-icon" src="/sites/all/themes/ema/file_icons/application-pdf.svg" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/report/report-industry-stakeholder-meeting-brexit-operation-centralised-procedure-human-medicinal-products_en-0.pdf" target="_blank" type="application/pdf; length=147926">report on EMA’s 24 September 2018 meeting with industry stakeholders</a> </span> to discuss the <a href="https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit" target="_self">UK’s withdrawal from the European Union</a> and the impact on the operation of the centralised procedure for human and veterinary medicines, published today, outlines how the European medicines regulatory network is preparing for Brexit, including <a href="https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/relocation-amsterdam" target="_self">EMA’s relocation</a> and business continuity planning.</p> <p><a href="https://www.ema.europa.eu/en/events/industry-stakeholder-meeting-brexit-operation-centralised-procedure-human-veterinary-medicines" target="_self">At the meeting</a>, participants were updated on EMA’s Brexit preparedness plans, which ensure that all core activities related to the evaluation and supervision of medicines continue uninterrupted, and to the same quality and timelines during the Agency’s relocation to Amsterdam and throughout 2019. With the exception of some <a href="https://www.ema.europa.eu/en/news/revised-timelines-certificates-pharmaceutical-products-cpps-temporary-arrangements-during-emas" target="_self">delays in processing of EMA certificates</a>, there should be no impact on other EMA procedures (e.g. scientific advice, orphan designation, paediatric investigation plans (PIPs), applications for marketing authorisation, post-authorisation activities). Companies are advised to submit applications and requests as normal.</p> <p>The Agency entered <span class="file"> <img alt="PDF icon" class="file-icon" src="/sites/all/themes/ema/file_icons/application-pdf.svg" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/other/ema-brexit-preparedness-business-continuity-plan-phase-3-implementation-plan_en.pdf" target="_blank" type="application/pdf; length=105723">phase 3 of its Brexit preparedness business continuity plan (BCP)</a> </span> on 1 October 2018, with the temporary suspension or reduction of some additional activities, including the scaling back of guideline development and revision, and the temporary putting on hold of non-product-related working parties. These steps have been taken to ensure that EMA can focus on its core business of protecting human and animal health and that freed-up resources can be redeployed to allow the Agency to safeguard its core activities related to the evaluation and supervision of medicines.</p> <p>The meeting was organised by EMA together with the European Commission and was attended by a broad range of industry stakeholders. Participants were again encouraged to submit all Brexit-related variation applications before end of 2018 to ensure that their marketing authorisations are compliant with EU pharmaceutical legislation before the departure of the UK from the EU.</p> <p>A further three industry stakeholder meetings on Brexit are planned for 2019.</p> </div> </div> </div>


EMA gives guidance on safety monitoring of medicines used in children, , 13/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>EMA has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population. It offers a holistic view of paediatric pharmacovigilance and provides guidance on how to make best use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children. In addition it advises on how to adapt regulatory requirements to the paediatric population in the European Union.</p> <p>The new GVP chapter covers approved medicines with a paediatric indication or with an ongoing paediatric development, but also medicines only approved for adults when they are used off-label to treat children, i.e. for a medical purpose not in accordance with the terms of the marketing authorisation.</p> <p>A dedicated approach to pharmacovigilance in children is especially important given that paediatric clinical trials are often limited in size and duration, and adverse reactions in children may substantially differ - in terms of frequency, nature, severity and presentation - from those occurring in adults.</p> <p>The guidance focuses on aspects of pharmacovigilance of particular relevance to the use of medicines in children, such as off-label use and medication errors, and contains paediatric-specific guidance on all major pharmacovigilance tools and processes, including risk management plans, periodic safety update reports, post-authorisation safety studies, signal management and safety communication.</p> <p>It also highlights the need to include comprehensive information in adverse drug reaction reports, such as the child’s age, weight and height, as well as, the indication or intention of use of the medicine, including its strength, dose and pharmaceutical form. This is important for all actors involved in safety reporting of medicines in children, including pharmaceutical companies, sponsors of clinical studies and regulatory authorities, but also parents/carers, healthcare professionals, patient and healthcare professional organisations, and organisations of national healthcare systems.</p> <p>The new GVP chapter was finalised after careful consideration of the extensive feedback received during a public consultation, and replaces EMA’s human medicines committee’s (CHMP) 2007 guideline on conduct of pharmacovigilance for medicines used by the paediatric population.</p> </div> </div> </div>


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018, , 16/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>EMA’s human medicines committee (CHMP) recommended four medicines for approval, including a medicine for use in countries outside the European Union, at its November 2018 meeting.</p> <p>The CHMP adopted a positive opinion for <strong>Fexinidazole Winthrop</strong> (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to <em>Trypanosoma brucei gambiense</em>. This is the tenth medicine recommended by EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on <a href="https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/medicines-use-outside-european-union">medicines for use outside the European Union</a>. For more information, please see the press release in the grid below.</p> <p><strong>Erleada</strong> (apalutamide) received a positive opinion for the treatment of non-metastatic castration resistant prostate cancer.</p> <p>The CHMP recommended granting a marketing authorisation for<strong> Macimorelin Aeterna Zentaris</strong> (macimorelin), for the diagnosis of growth hormone deficiency in adults.</p> <p>The generic medicine <strong>Silodosin Recordati</strong> (silodosin) received a positive opinion from the CHMP for the treatment of the signs and symptoms of benign prostatic hyperplasia.</p> <p><strong>Four recommendations on extensions of therapeutic indication</strong></p> <p>The Committee recommended extensions of indication for <strong>Kisqali</strong>, <strong>Mabthera</strong>, <strong>Orkambi</strong> and <strong>Ravicti</strong>.</p> <p><strong>Positive recommendations on extension of therapeutic indication following re-examination</strong></p> <p>The Committee recommended an extension of therapeutic indication for <strong>Blincyto</strong> (blinatumomab) in patients with residual cancer cells in the body after previous treatment, after re-examining its negative opinion for this medicine adopted in July 2018.</p> <p>The CHMP also adopted a positive opinion for the use of <strong>Opdivo</strong> (nivolumab) and <strong>Yervoy</strong> (ipilimumab) in combination to treat renal cell carcinoma (kidney cancer), after re-examining its negative opinion adopted in July 2018.</p> <p>For more information on these positive opinions following re-examination please see the question-and-answer documents in the grid below.</p> <p><strong>Outcome of review on quinolone and fluoroquinolone antibiotics</strong></p> <p>The CHMP recommended suspending some <strong>quinolone and fluoroquinolone antibiotics</strong> and introducing changes including restrictions on the use of all others following a review of disabling and potentially permanent side effects reported with these medicines. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on these medicines in June 2018. For more information, please see the public health recommendation in the grid below.</p> <p><strong>Withdrawal of extension of indication application</strong></p> <p>The application to extend the use of <strong>Tecentriq</strong> (atezolizumab) to treat kidney cancer was withdrawn. A question-and-answer document on this withdrawal is available in the grid below.</p> <p><strong>Agenda and minutes</strong></p> <p>The agenda of the November 2018 meeting is published on EMA's website. Minutes of the October 2018 CHMP meeting will be published in the coming weeks.</p> <p><strong>CHMP statistics</strong></p> <p>Key figures from the November 2018 CHMP meeting are represented in the graphic below.</p> <p><img alt=" November 2018" data-delta="3" data-fid="200874" data-media-element="1" src="https://www.ema.europa.eu/sites/default/files/chmp_highlights_november_2018.jpg" typeof="Image" /></p> </div> </div> </div> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="positive-recommendations-on-new-medicines-section" id="positive-recommendations-on-new-medicines-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Positive recommendations on new medicines</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Erleada</th> </tr></thead><tbody><tr><td>INN</td> <td>apalutamide</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Janssen-Cilag International N.V.</td> </tr><tr><td>Therapeutic indication</td> <td>Treatment of non-metastatic castration resistant prostate cancer</td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-erleada_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP summary of positive opinion for Erleada <small class="ema-u-color-grey-2"> (PDF/61.01 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/CHMP/784876/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p> </p> <table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Macimorelin Aeterna Zentaris</th> </tr></thead><tbody><tr><td>INN</td> <td>macimorelin</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Aeterna Zentaris GmbH</td> </tr><tr><td>Therapeutic indication</td> <td>Diagnosis of growth hormone deficiency in adults</td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-macimorelin-aeterna-zentaris_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP summary of positive opinion for Macimorelin Aeterna Zentaris <small class="ema-u-color-grey-2"> (PDF/62.48 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/CHMP/777751/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="positive-recommendation-on-new-generic-medicine-section" id="positive-recommendation-on-new-generic-medicine-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Positive recommendation on new generic medicine</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Silodosin Recordati</th> </tr></thead><tbody><tr><td>INN</td> <td>silodosin</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Recordati Ireland Ltd</td> </tr><tr><td>Therapeutic indication</td> <td>Treatment of the signs and symptoms of benign prostatic hyperplasia</td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-silodosin-recordati_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP summary of positive opinion for Silodosin Recordati <small class="ema-u-color-grey-2"> (PDF/73.33 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/766073/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="positive-recommendation-on-medicine-for-use-outside-the-european-union-section" id="positive-recommendation-on-medicine-for-use-outside-the-european-union-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Positive recommendation on medicine for use outside the European Union</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Fexinidazole Winthrop</th> </tr></thead><tbody><tr><td>INN</td> <td>fexinidazole</td> </tr><tr><td>Opinion holder</td> <td>sanofi-aventis groupe</td> </tr><tr><td>Therapeutic indication</td> <td>Treatment of human African trypanosomiasis (HAT) due to <em>Trypanosoma brucei gambiense</em></td> </tr><tr><td>More information</td> <td>Press release: <a href="https://www.ema.europa.eu/en/news/chmp-recommends-first-oral-only-treatment-sleeping-sickness">CHMP recommends first oral-only treatment for sleeping sickness</a></td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop-initial/chmp-summary-opinion-fexinidazole-winthrop_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP summary of opinion for Fexinidazole Winthrop <small class="ema-u-color-grey-2"> (PDF/73.53 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/791484/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="positive-recommendations-on-extensions-of-indications-section" id="positive-recommendations-on-extensions-of-indications-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Positive recommendations on extensions of indications</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Kisqali</th> </tr></thead><tbody><tr><td>INN</td> <td>ribociclib</td> </tr><tr><td>Marketing-authorisation applicant</td> <td> <p>Novartis Europharm Limited</p> </td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-kisqali-ii-04_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP post-authorisation summary of positive opinion for Kisqali (II-04) <small class="ema-u-color-grey-2"> (PDF/64.74 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/CHMP/795769/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p> </p> <table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Mabthera</th> </tr></thead><tbody><tr><td>INN</td> <td>rituximab</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Roche Registration GmbH</td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-mabthera-ii-149_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP post-authorisation summary of positive opinion for MabThera (II-149) <small class="ema-u-color-grey-2"> (PDF/71.67 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/CHMP/790642/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p> </p> <table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Orkambi</th> </tr></thead><tbody><tr><td>INN</td> <td>lumacaftor / ivacaftor</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Vertex Pharmaceuticals (Europe) Ltd</td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-orkambi-x-34-g_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP post-authorisation summary of positive opinion for Orkambi (X-34-G) <small class="ema-u-color-grey-2"> (PDF/67.93 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/774653/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p> </p> <table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Ravicti</th> </tr></thead><tbody><tr><td>INN</td> <td>glycerol phenylbutyrate</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Horizon Pharma Ireland Limited</td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-ravicti-ii-19_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP post-authorisation summary of positive opinion for Ravicti (II-19) <small class="ema-u-color-grey-2"> (PDF/72.76 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/CHMP/801110/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="positive-recommendations-on-extensions-of-indications-following-re-examination-section" id="positive-recommendations-on-extensions-of-indications-following-re-examination-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Positive recommendations on extensions of indications following re-examination</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Blincyto</th> </tr></thead><tbody><tr><td>INN</td> <td>blinatumomab</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Amgen Europe B.V.</td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-blincyto-ii-0011_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP post-authorisation summary of positive opinion for Blincyto (II-0011) <small class="ema-u-color-grey-2"> (PDF/69.16 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/CHMP/799482/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/medicine-qa/questions-answers-positive-opinion-change-marketing-authorisation-blincyto-blinatumomab_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Questions and answers on the positive opinion on the change to the marketing authorisation for Blincyto (blinatumomab) <small class="ema-u-color-grey-2"> (PDF/76.47 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/800602/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p> </p> <table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Opdivo</th> </tr></thead><tbody><tr><td>INN</td> <td>nivolumab</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Bristol-Myers Squibb Pharma EEIG</td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-opdivo-ws-1278_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP post-authorisation summary of positive opinion for Opdivo (WS-1278) <small class="ema-u-color-grey-2"> (PDF/72.85 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/CHMP/788598/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/medicine-qa/questions-answers-positive-opinion-change-marketing-authorisation-opdivo-nivolumab-yervoy-ipilimumab_en-0.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Questions and answers on positive opinion on the change to the marketing authorisation for Opdivo (nivolumab) and Yervoy (ipilimumab) <small class="ema-u-color-grey-2"> (PDF/77.43 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 16/11/2018 <br/> EMA/799169/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p> </p> <table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Yervoy</th> </tr></thead><tbody><tr><td>INN</td> <td>ipilimumab</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Bristol-Myers Squibb Pharma EEIG</td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/smop/chmp-post-authorisation-summary-positive-opinion-yervoy-ws-1278_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP post-authorisation summary of positive opinion for Yervoy (WS-1278) <small class="ema-u-color-grey-2"> (PDF/71.11 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/795695/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/medicine-qa/questions-answers-positive-opinion-change-marketing-authorisation-opdivo-nivolumab-yervoy-ipilimumab_en-0.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Questions and answers on positive opinion on the change to the marketing authorisation for Opdivo (nivolumab) and Yervoy (ipilimumab) <small class="ema-u-color-grey-2"> (PDF/77.43 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 16/11/2018 <br/> EMA/799169/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="public-health-recommendation-section" id="public-health-recommendation-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Public-health recommendation</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Quinolone- and fluoroquinolone-containing medicinal products</th> </tr></thead><tbody><tr><td>INN</td> <td>nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin</td> </tr><tr><td>More information</td> <td><a class="ecl-link" href="https://www.ema.europa.eu/en/news/disabling-potentially-permanent-side-effects-lead-suspension-restrictions-quinolone-fluoroquinolone">Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics </a></td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/referral/quinolone-fluoroquinolone-article-31-referral-disabling-potentially-permanent-side-effects-lead_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Quinolone and fluoroquinolone Article-31 referral - Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics <small class="ema-u-color-grey-2"> (PDF/81.98 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 16/11/2018 <br/> EMA/795349/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="outcomes-of-arbitration-procedures-section" id="outcomes-of-arbitration-procedures-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Outcomes of arbitration procedures</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Diclofenac sodium spray gel 4%</th> </tr></thead><tbody><tr><td>INN</td> <td>diclofenac</td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/referral/diclofenac-article-294-referral-ema-recommends-authorisation-diclofenac-sodium-spray-gel-4_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Diclofenac Article 29(4) referral - EMA recommends authorisation of Diclofenac Sodium Spray Gel 4% (diclofenac) in the EU <small class="ema-u-color-grey-2"> (PDF/77.59 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 16/11/2018 <br/> EMA/631720/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p> </p> <table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Diotop capsules</th> </tr></thead><tbody><tr><td>INN</td> <td>diclofenac / omeprazole</td> </tr></tbody></table><p> </p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/referral/diotop-article-294-referral-ema-recommends-authorisation-diotop-diclofenac/omeprazole-capsules-eu_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Diotop Article 29(4) referral - EMA recommends authorisation of Diotop (diclofenac / omeprazole capsules) in the EU <small class="ema-u-color-grey-2"> (PDF/76.5 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 16/11/2018 <br/> EMA/790726/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="withdrawal-of-extension-of-indication-application-section" id="withdrawal-of-extension-of-indication-application-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Withdrawal of extension of indication application</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="0" cellpadding="1" cellspacing="1"><thead><tr><th scope="col" style="background-color:rgb(227, 227, 227)">Name of medicine</th> <th scope="col" style="background-color:rgb(227, 227, 227)">Tecentriq</th> </tr></thead><tbody><tr><td>INN</td> <td>atezolizumab</td> </tr><tr><td>Marketing-authorisation applicant</td> <td>Roche Registration GmbH</td> </tr></tbody></table></div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-tecentriq-atezolizumab_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Questions and answers on the withdrawal of application for a change to the marketing authorisation for Tecentriq (atezolizumab) <small class="ema-u-color-grey-2"> (PDF/112.51 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 16/11/2018 <br/> EMA/798527/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="other-updates-section" id="other-updates-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Other updates</h3> </div> </div> </div> </div> <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/chmp-annex/start-community-reviews-chmp-meeting-12-15-november-2018_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Start of community reviews - CHMP meeting of 12-15 November 2018 <small class="ema-u-color-grey-2"> (PDF/66.92 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 16/11/2018 <br/> EMA/712987/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/chmp-annex/scientific-advice-protocol-assistance-adopted-during-chmp-meeting-12-15-november-2018_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Scientific advice and protocol assistance adopted during the CHMP meeting 12-15 November 2018 <small class="ema-u-color-grey-2"> (PDF/123.54 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Adopted<br/> <br /> First published: 16/11/2018 <br/> EMA/CHMP/SAWP/800757/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


CHMP recommends first oral-only treatment for sleeping sickness, , 16/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>EMA’s human medicines committee (CHMP) has adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness, due to <em>Trypanosoma brucei</em> <em>gambiense</em>.</p> <p>This is the tenth medicine recommended by EMA under <a href="https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/medicines-use-outside-european-union">Article 58</a>, a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the European Union.</p> <p>HAT is a life-threatening, neglected tropical disease that is endemic in sub-Saharan Africa. There are two forms of sleeping sickness, depending on the parasite involved: <em>Trypanosoma brucei gambiense</em> or <em>Trypanosoma brucei rhodesiense</em>. The vast majority (98%) of reported cases are caused by <em>T. b. gambiense</em>. Most cases occur in the Democratic Republic of the Congo, with the remainder located in bordering central African countries.</p> <p>HAT caused by <em>T. b. gambiense</em> is characterised by a more chronic disease evolution. Within a few weeks of infection, patients can experience bouts of fever, headaches, joint and muscle pains and itching. Over time the disease invades the central nervous system. Patients display neurological signs including mental confusion, slurred speech, seizures, difficulty in walking and talking and worsening sleep disturbances. If left untreated, the disease is usually fatal within a time span of two to three years.</p> <p>Current therapy is selected based on how much the central nervous system is affected. Treatments include intramuscular injections of pentamidine, which are painful and only adequate for the earlier stage of the disease. Other treatments are available, e.g. a combination of oral nifurtimox and intravenous infusion of eflornithine (NECT) as reference therapy when the disease has advanced and affects the central nervous system. However, all these treatments require a minimum health infrastructure and personnel, not readily available in some remote areas.</p> <p>Fexinidazole Winthrop, as exclusively oral treatment regimen for the disease, could potentially allow quicker and wider access to treatment because distribution and administration of tablets is easier. It was developed by the applicant in partnership with the Drugs for Neglected Diseases initiative, a non-profit drug research and development organisation based in Switzerland.</p> <p>The benefits and safety of Fexinidazole Winthrop were evaluated in three clinical studies involving 749 patients across the different stages of the disease. The studies showed high cure rates in patients after ten days of treatment, especially in the earlier stage of the disease. However, for patients whose central nervous system is already severely affected, Fexinidazole should only be given under strict supervision in hospital when no other adequate treatment is available or tolerated.</p> <p>The most common side effects observed were vomiting, nausea, headache, insomnia, weakness, dizziness and tremor.</p> <p>Because there were a small number of cases of late relapse in the studies, the CHMP recommends a follow-up monitoring of up to 24 months to ensure the surveillance of potential relapses. All eligible patients should receive Fexinidazole under supervision of trained healthcare staff to ensure full compliance.</p> <p>Fexinidazole Winthrop was submitted to EMA under a regulatory procedure (Article 58) which allows the Agency to assess the quality, safety and efficacy of a medicine and give an opinion on its benefit-risk balance when used in low- and middle-income countries outside the EU. Medicines submitted under this programme are assessed by EMA in collaboration with the World Health Organization (WHO). They must meet the same standards as medicines intended for EU citizens. More information is available on the  <span class="file"> <img alt="PDF icon" class="file-icon" src="/sites/all/themes/ema/file_icons/application-pdf.svg" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/leaflet/infographic-article-58-procedure_en.pdf" target="_blank" type="application/pdf; length=2400995">infographic on Article 58 procedure</a> </span> .</p> <p>The scientific opinion from the CHMP helps to support regulators in countries where regulatory capacity may be limited, by providing an expert evaluation of the medicine when used in local practice. National regulators can use the CHMP's scientific assessment to decide on the use of the medicine in their countries.</p> <div> <p><strong>Notes</strong></p> <p>The applicant for Fexinidazole Winthrop is sanofi-aventis groupe.</p> </div> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/chmp-recommends-first-oral-only-treatment-sleeping-sickness_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> CHMP recommends first oral-only treatment for sleeping sickness <small class="ema-u-color-grey-2"> (PDF/72.62 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 16/11/2018 <br/> EMA/CHMP/798734/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics , , 16/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>EMA has reviewed serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018.</p> <p>EMA’s human medicines committee (CHMP) has endorsed the recommendations of EMA’s safety committee (PRAC) and concluded that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid should be suspended.</p> <p>The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted. In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system.</p> <p>Restrictions on the use of fluoroquinolone antibiotics will mean that they should <strong>not</strong> be used:</p> <ul><li>to treat infections that might get better without treatment or are not severe (such as throat infections);</li> <li>to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;</li> <li>for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);</li> <li>to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.</li> </ul><p>Importantly, fluoroquinolones should generally be <strong>avoided</strong> in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used <strong>with special caution</strong> in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.</p> <p>The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU countries. National authorities will enforce this decision for the fluoroquinolone and quinolone medicines authorised in their countries and they will also take other appropriate measures to promote the correct use of these antibiotics.</p> <p><strong>Information for patients</strong></p> <ul><li>Fluoroquinolone medicines (which contain ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin) can cause long-lasting, disabling and potentially permanent side effects involving tendons, muscles, joints and the nervous system.</li> <li>These serious side effects include inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling, walking difficulty, feeling pins and needles, burning pain, tiredness, depression, problems with memory, sleeping, vision and hearing, and altered taste and smell.</li> <li>Tendon swelling and injury may occur within 2 days of starting treatment with a fluoroquinolone but may even occur several months after stopping treatment.</li> <li>Stop taking a fluoroquinolone medicine and contact your doctor at once in the following cases: <ul style="list-style-type:circle"><li>at the first sign of tendon injury, such as tendon pain or swelling – rest the painful area;</li> <li>if you get pain, feel pins and needles, tingling, tickling, numbness or burning, or weakness especially in the legs or arms;</li> <li>if you get swelling in the shoulder, arms or legs, have walking difficulty, feel tired or depressed or have problems with your memory or with sleeping or you notice changes with your vision, taste, smell or hearing. You and your doctor will decide if you can continue treatment or if you need to take another type of antibiotic.</li> </ul></li> <li>You may be more prone to joint pain or swelling or tendon damage if you are aged over 60 years, your kidneys do not work well or you have received organ transplantation.</li> <li>Speak with your doctor if you are taking a corticosteroid (medicines such as hydrocortisone and prednisolone) or need to have treatment with a corticosteroid. You may be especially prone to tendon damage if you are taking a corticosteroid and a fluoroquinolone medicine at the same time.</li> <li>You should not take a fluoroquinolone medicine if you have ever had a serious side effect with a fluoroquinolone or a quinolone medicine and you should speak with your doctor immediately.</li> <li>If you have any questions or concerns about your medicines, speak to your doctor or pharmacist.</li> </ul><p><strong>Information for healthcare professionals</strong></p> <ul><li>Fluoroquinolones are associated with prolonged (up to months or years), serious, disabling and potentially irreversible drug reactions affecting several, sometimes multiple, systems, organ classes and senses.</li> <li>The serious side effects include tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impaired hearing, vision, taste and smell.</li> <li>Tendon damage (especially to Achilles tendon but also other tendons) can occur within 48 hours of starting fluoroquinolone treatment but the damage may be delayed several months after stopping treatment.</li> <li>Patients who are older, have renal impairment or have had solid organ transplantation and those being treated with a corticosteroid are at higher risk of tendon damage. Concomitant treatment with a fluoroquinolone and a corticosteroid should be avoided.</li> <li>Fluoroquinolone treatment should be discontinued at the first sign of tendon pain or inflammation and patients should be advised to stop treatment with a fluoroquinolone and speak with the doctor in case of symptoms of neuropathy such as pain, burning, tingling, numbness or weakness so as to prevent development of potentially irreversible condition.</li> <li>Fluoroquinolones should generally not be used in patients who have had serious adverse reactions associated with the use of quinolone or fluoroquinolone medicines.</li> <li>Up-to-date summary of product characteristics should be consulted for authorised indications when considering treatment with a fluoroquinolone medicine. This is because the indications for these medicines have been restricted.</li> <li>The benefits and risks of fluoroquinolones will be monitored continuously and a drug utilisation study will evaluate the effectiveness of the new measures to reduce inappropriate use of fluoroquinolones by investigating changes in prescribing behaviour. </li> </ul><div> <hr /><p><strong>More about the medicine</strong></p> </div> <p>Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are active against bacteria of both Gram-negative and Gram-positive classes. Fluoroquinolones are of value in certain infections, including some life-threatening ones, where alternative antibiotics are not sufficiently effective.</p> <p>The review covered medicines containing the following fluoroquinolone and quinolone antibiotics: cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin.</p> <p>The review concerned only medicines given systemically (by mouth or injection) and inhaled medicines.</p> <p><strong>More about the procedure</strong></p> <p>The review of fluoroquinolones and quinolones was initiated on 9 February 2017 at the request of the German medicines authority (BfArM), under <a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000150.jsp&mid=WC0b01ac05800240d0">Article 31 of Directive 2001/83/EC</a>.</p> <p>The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.</p> <p>The final PRAC recommendations were adopted on 4 October 2018 and then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.</p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/disabling-potentially-permanent-side-effects-lead-suspension-restrictions-quinolone-fluoroquinolone_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics <small class="ema-u-color-grey-2"> (PDF/81.98 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 16/11/2018 <br/> EMA/795349/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity, , 19/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India.</p> <p>EDQM<sup>1</sup> has now suspended the manufacturer’s CEP<sup>2</sup> (a certificate of compliance with European standards for quality testing), effectively prohibiting the use of its valsartan in EU medicines.</p> <p>In addition, national authorities in the EU have started recalling affected batches of medicines containing Mylan’s valsartan and are conducting further tests to determine the extent of the contamination.</p> <p>NDEA and the related compound N-nitrosodimethylamine (NDMA), which have been seen in ‘sartans’ from other manufacturers, are classified as probable human carcinogens (substances that could cause cancer).</p> <p>As with previous findings of NDEA and NDMA, there is no immediate risk to patients. It is riskier for patients to suddenly stop taking high blood pressure medication. Patients should therefore not stop any treatments without consulting their doctor or pharmacist.</p> <p>The presence of impurities in valsartan medicines and other sartans is thought to be linked to the synthesis of a specific ring structure (tetrazole) which is present in some sartan medicines. <a href="https://www.ema.europa.eu/en/medicines/human/referrals/angiotensin-ii-receptor-antagonists-sartans-containing-tetrazole-group">EMA's review of sartans</a> with this structure is continuing and the Agency is working closely with national authorities, international partners and the EDQM.</p> <p>Companies marketing sartan medicines in the EU have been asked to test their products for these impurities. Additional testing is being carried out by EU laboratories. EMA will update the public as soon as new information becomes available.</p> <p>EMA is also working with manufacturers to determine what measures can be taken to reduce or eliminate the impurities from future batches of their products.</p> <div> <hr /><p> </p> </div> <p><strong>More about the medicine</strong></p> <p>Valsartan is an angiotensin-II-receptor antagonist used to treat hypertension (high blood pressure), recent heart attack and heart failure. It is available on its own or in combination with other active substances.</p> <p>Medicines containing valsartan as the only active substances have been authorised in the EU via national authorities. Nine products containing valsartan in combination with other active substance have been authorised centrally.</p> <p><strong>More about the procedure</strong></p> <p>The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under <a href="https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures">Article 31 of Directive 2001/83/EC</a>. On 20 September 2018, the review was extended to include medicines containing candesartan, irbesartan, losartan and olmesartan.</p> <p>The review is being carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.</p> <div> <hr />  <div id="ftn1"> <p><sup>1</sup> European Directorate for the Quality of Medicines and Healthcare</p> <p><sup>2</sup> CEP: <a href="https://www.edqm.eu/en/certificate-suitability-new-applications" target="_blank">certificate of suitability to the monographs of the European Pharmacopoeia</a></p> </div> </div> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/valsartan-mylan-laboratories-india-can-no-longer-be-used-eu-medicines-due-ndea-impurity_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity <small class="ema-u-color-grey-2"> (PDF/193.07 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 19/11/2018 <br/> EMA/809509/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy applications, , 20/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p> <img alt="manufacturing quality data" class="file-default media-element" data-delta="1" height="3456" src="https://www.ema.europa.eu/sites/default/files/quality_data.jpg" style="height: 200px; width: 300px; margin: 20px; float: left;" typeof="foaf:Image" width="5184" /> EMA and the US Food and Drug Administration (FDA) are organising a <a href="https://www.ema.europa.eu/en/events/stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-breakthrough" target="_self">workshop on 26 November 2018</a> to discuss how regulators can better guide and support medicine developers in generating quality and manufacturing data packages in the context of development support programmes, such as the <a href="https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines" target="_self">PRIority MEdicines scheme (PRIME)</a> in the EU and <a href="https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm">Breakthrough Therapy</a> designation programme in the US. The goal is to help patients to benefit as early as possible from these therapies that target serious or life-threatening diseases or unmet medical needs. </p> <p>Since the launch of EMA’s PRIME scheme in 2016, and FDA’s Breakthrough Therapy designation programme in 2012, both programmes have succeeded in driving innovation and encouraging drug development in therapeutic areas with the most pressing serious or life-threatening diseases and unmet medical needs. However, experience gained with these programmes has shown that applicants who are part of the scheme often face challenges in meeting the data requirements on quality and manufacturing development. </p> <p>The aim of the workshop is to discuss scientific and regulatory approaches which could be used to facilitate development and preparation of robust quality data packages, to enable timely access to medicines for patients whilst assuring that patient safety and product quality are not compromised. </p> <p>The event, which is a joint collaboration between EMA and the <a href="https://www.fda.gov/">US Food and Drug Administration (FDA)</a>, intends to explore opportunities and best practices between the agencies and industry to further facilitate the successful development and authorisation of priority medicines. </p> <p>This workshop will also bring together experts from EMA's Biologics Working Party, Quality Working Party and Inspectors Working Group, international partners and industry representatives. Participants have been invited to submit case studies related to key manufacturing challenges (e.g. control strategy, stability) prior to the meeting. Some of these will be discussed during the event to explore scientific and regulatory approaches that could be used to overcome those challenges. </p> <p>EMA will publish a report on the workshop on its website. Additionally, the Agency will consider the opportunity to develop recommendations and further guidance for applicants based on the experience gained so far and the feedback received during the event. </p> <p>The workshop will be held from 9:00 to 17:30 UK time at the EMA premises in London. It will be broadcast live and can be followed by clicking on the 'multimedia' tab on the event page. An  <span class="file"> <img alt="PDF icon" class="file-icon" src="/sites/all/themes/ema/file_icons/application-pdf.svg" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/agenda/agenda-workshop-stakeholders-support-quality-development-early-access-approaches-ie-prime_en.pdf" target="_blank" type="application/pdf; length=142679">updated programme of the event</a> </span> is available. </p> </div> </div> </div>


Towards electronic product information for EU medicines, , 21/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are organising a <a href="https://www.ema.europa.eu/en/events/european-medicines-agency-ema-heads-medicines-agencies-hma-european-commission-ec-workshop" target="_self">workshop on 28 November 2018</a> in London to agree with various stakeholders on common European Union key principles to pave the way for implementing electronic product information (ePI) in the EU.</p> <p>The product information (PI) of a medicine in the EU includes the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals. These documents accompany every single medicine authorised in the EU and explain how it should be used and prescribed.</p> <p>The workshop follows up on an <a href="https://ec.europa.eu/health/sites/health/files/files/documents/2017_03_report_smpc-pl_en.pdf">EC report</a> highlighting that, despite efforts to make the PI easy to read and useful, there is still a need to improve how information on medicines is conveyed to patients and healthcare professionals.</p> <p>One of the key areas of this report is to explore how electronic formats can be used to improve citizens’ access to medicines' information. The package leaflet is currently provided in the medicine’s box and can also be found, mainly as a pdf document, on the regulators’ websites. However, novel digital platforms open additional possibilities to disseminate the package leaflet electronically. This can enhance access to up-to-date information and offer new opportunities to better tailor this information to the needs of patients. In addition, ePI will support patients with visual impairments and citizens with low literacy levels.</p> <p>The workshop offers a platform for healthcare professionals, patients and consumers, academics, non-profit organisations, regulators and the pharmaceutical industry to discuss:</p> <ul><li>opportunities, needs and concerns identified by different stakeholder groups;</li> <li>ongoing initiatives in the EU;</li> <li>how ePI fits into other EU and global initiatives.</li> </ul><p>The outcome of the workshop will serve as a basis to draft key principles for the use of ePI in the EU, which will be released for a six-month public consultation in January 2019.</p> <p>The workshop will be live streamed on EMA’s website. No registration or password is required. Participants interested in tweeting about this event are invited to use the hashtag <strong>#ePI4Medicines.</strong></p> <p>Progress on using electronic means for a better dissemination of product information in Europe is one of the key priorities of the <a href="https://www.ema.europa.eu/documents/other/european-medicines-agency-action-plan-related-european-commissions-recommendations-product_en.pdf">action plan</a> that EMA published in 2017 to address the shortcomings identified in the EC report and to improve the PI for EU medicines. In addition to electronic formats for the PI, other initiatives focus on:</p> <ul><li>how to make the package leaflet easier to understand for EU citizens;</li> <li>strengthening patients' input during the preparation of the package leaflet;</li> <li>updating EU guidance and sharing best practices on preparing the package leaflet.</li> </ul><p>The timelines of these activities may need to be adjusted in view of EMA's <a href="https://www.ema.europa.eu/documents/other/european-medicines-agency-brexit-preparedness-business-continuity-plan_en.pdf">business continuity plan</a> in the context of <a href="https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit">Brexit</a> and the Agency's upcoming relocation to the Netherlands. EMA and the EC are committed to working together with EU Member States to successfully implement the action plan. All relevant stakeholders will be involved as their input is crucial to ensure that their needs are addressed.</p> </div> </div> </div> , <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/press-release/towards-electronic-product-information-eu-medicines_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Towards electronic product information for EU medicines <small class="ema-u-color-grey-2"> (PDF/56.69 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> <br /> First published: 21/11/2018 <br/> EMA/799809/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul>


Workshop: advancing regulatory science to 2025 for veterinary medicines, , 29/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>EMA is holding a <a href="https://www.ema.europa.eu/en/events/multi-stakeholder-workshop-launch-consultation-european-medicines-agency-ema-veterinary-regulatory" target="_self">workshop on Thursday, 6 December 2018</a> in London to gather views from a wide range of stakeholders concerning key areas in veterinary medicines to be covered in the Agency’s Regulatory Science Strategy to 2025.</p> <p>Innovation in veterinary medicines has made significant progress over the last few years. In addition, the upcoming veterinary legislation will have a major impact on the development and regulation of medicines for animals.</p> <p>To keep pace with these advances and ensure the sound assessment of ground-breaking, more complex therapies, regulators need to have optimal tools to improve ‘regulatory science’ – a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicines and that inform regulatory decision-making throughout the lifecycle of a medicine.</p> <p>Therefore, EMA is developing a ‘Regulatory Science to 2025’ strategy, a strategic plan for advancing regulatory science over the next five to ten  years, covering both human and veterinary medicines.</p> <p>­­­­The workshop will bring together veterinarians, representatives from the veterinary pharmaceutical industry, academia, trade associations and regulators. The participants will have the opportunity to reflect on the scientific and technological advances in the area of veterinary medicines, as well as the challenges that EMA’s scientific committees and working parties will face in the future. The workshop will also facilitate discussions on ways to address emerging health threats like <a href="https://www.ema.europa.eu/en/veterinary-regulatory/overview/antimicrobial-resistance-veterinary-medicine" target="_self">antimicrobial resistance</a> and the availability of medicines. In addition, it will highlight areas relevant to various stakeholder groups in advance of a six-month public consultation on the proposed strategy to be launched in December 2018.</p> <p>An <a href="https://www.ema.europa.eu/en/agenda/agenda-regulatory-science-2025-launch-veterinary-stakeholder-consultation" target="_self">agenda of the workshop</a> is available. The workshop can be followed live in the ‘multimedia’ section on the <a href="https://www.ema.europa.eu/en/events/multi-stakeholder-workshop-launch-consultation-european-medicines-agency-ema-veterinary-regulatory" target="_self">event page</a>. Presentations and a recording of the workshop will be published.</p> <p>Participants are encouraged to tweet using the following hashtag: #RegScience2025.</p> <p><strong>Key priorities of the Regulatory Science Strategy to 2025</strong></p> <p>The ‘Regulatory Science Strategy to 2025’ aims to identify key areas where new or enhanced engagement of the network is essential and where advances in regulatory science will need to be adopted. It will help shape the vision for the next EU Medicines Agencies Network Strategy (2020–2025).</p> <p>The five key goals of the strategy include:</p> <ul><li>catalysing the integration of science and technology in medicine development;</li> <li>driving collaborative evidence generation;</li> <li>improving the scientific quality of evaluations;</li> <li>addressing emerging health threats and availability/therapeutic challenges;</li> <li>enabling and leveraging research and innovation in regulatory science.</li> </ul></div> </div> </div>


Five additional countries to benefit from EU-US mutual recognition agreement for inspections, , 29/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>In November 2018, the US <a href="https://www.fda.gov/">Food and Drug Administration (FDA)</a> confirmed the capability of five additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Belgium, Denmark, Finland and Latvia were included into the <a href="https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements-mra" target="_self">mutual recognition agreement</a> between the European Union (EU) and the United States (US) on 16 November and Estonia on 28 November 2018. The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories and as of today, the FDA will rely on a total of 20 Member States whose inspection results can replace their own inspections.</p> <p>In June 2017, the <a href="https://ec.europa.eu/commission/index_en">European Commission</a> confirmed that the FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. Since<br /> 1 November 2017, EU Member States and EMA can rely on inspection results from the FDA.</p> <p>Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track.</p> <p>The mutual recognition agreement between EU and US regulators strengthens reliance on each other's inspection expertise and resources. Mutual benefits for EU authorities and the FDA include:</p> <ul><li>the ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured;</li> <li>prioritising inspections of medicines manufacturing sites for higher risk cases;</li> <li>reassuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured;</li> <li>improving the ability to identify and address potential problems at manufacturing sites before they become a public health risk;</li> <li>reducing the administrative burden and costs from duplicative inspections for pharmaceutical manufacturers, including smaller producers.</li> </ul><p>The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU national competent authorities, EMA and the FDA have been auditing and assessing the respective supervisory systems since May 2014, and are working closely together to reach the agreement’s milestones.</p> </div> </div> </div>


Revised guideline to assess risk of human medicines for the environment, , 30/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p><img alt="Environmental risk assessment" data-delta="3" data-fid="202989" data-media-element="1" src="https://www.ema.europa.eu/sites/default/files/environmental_risk_assessment.png" style="height:225px; width:300px; margin:20px; float:left" typeof="Image" />EMA has published a  <span class="file"> <img alt="PDF icon" class="file-icon" src="/sites/all/themes/ema/file_icons/application-pdf.svg" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/scientific-guideline/draft-guideline-environmental-risk-assessment-medicinal-products-human-use-revision-1_en.pdf" target="_blank" type="application/pdf; length=714554">revision of its guideline on the environmental risk assessment (ERA) of human medicines</a> </span> for a six-month public consultation. Stakeholders are invited to send their comments by 30 June 2019 to <a href="mailto:ERA_DG@ema.europa.eu">era_dg@ema.europa.eu</a> using the <span class="file"> <img alt="Microsoft Office document icon" class="file-icon" src="/sites/all/themes/ema/file_icons/x-office-document.svg" title="application/msword" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/template-form/form-submission-comments-scientific-guidelines_en.doc" target="_blank" type="application/msword; length=157696">template</a> </span> provided.</p> <p>The presence of biologically-active pharmaceuticals in the environment is a growing concern, because some of these substances have shown direct effects on wildlife at or below the concentrations found in water and soil. For example, male fish exposed to the main ingredient in the contraceptive pill may become feminised and this can affect the capacity of the population to reproduce. Pharmaceuticals may also have indirect effects e.g. a <a href="https://www.nature.com/articles/s41467-018-06822-w.pdf">recent study</a> shows that pharmaceutical compounds detected in surface waters can transfer from invertebrate larvae to the predators that feed on them.</p> <p>Human medicines may enter the environment during their manufacture, use and disposal. The ERA is based on the use of the product and the physico-chemical, ecotoxicological and fate properties (degradation, persistence) of its active substance.</p> <p>Environmental risk assessment of medicines ensures that the potential effects of pharmaceuticals on the environment are studied and that adequate precautions are taken in case specific risks are identified. Performing an ERA is mandatory for any pharmaceutical company submitting a marketing authorisation application for a medicine, regardless of the type of medicine. Appropriate details are included in the European Public Assessment Report (EPAR) of approved medicines, so that this information is available to the public.</p> <p>The revision of EMA’s guideline on ERA introduces a decision tree clarifying when ERA studies are required and provides more detailed technical guidance to applicants to increase the consistency of the assessments.</p> <p>One of the most notable changes introduced in the proposed revision is the introduction of the term ‘endocrine active substances’, to include all compounds that affect development or reproduction. Additionally, guidance is provided for the estimation of the exposure of predators to pharmaceuticals through the food chain (‘secondary poisoning’), as well as directly through the environment. The revision also proposes to limit the use of a laboratory test method - the <a href="https://www.oecd-ilibrary.org/fr/environment/test-no-308-aerobic-and-anaerobic-transformation-in-aquatic-sediment-systems_9789264070523-en">Organisation for Economic Co-operation and Development (OECD) 308 environmental fate test</a> - to certain categories of substances and this will reduce the burden of testing on applicants.</p> <p>The revision of the ERA guideline is based on a concept paper issued in 2014 and the work of a group of experts led by the <a class="ecl-link" href="https://www.ema.europa.eu/en/committes/working-parties-other-groups/chmp/safety-working-party">Safety Working Party</a> of EMA’s <a href="https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp" target="_self">human medicines committee (CHMP)</a>. It builds on the twelve years of experience gained since the original guideline was published and aims to facilitate the work for both applicants and regulators in the interest of environmental protection.</p> <p>In the interest of animal welfare, the guideline encourages applicants to share data generated for the ERA, implementing the <a href="https://www.ema.europa.eu/en/human-regulatory/research-development/ethical-use-animals-medicine-testing" target="_self">principles of 3Rs (Replacement, Reduction and Refinement)</a> - in accordance with <a href="http://ec.europa.eu/environment/chemicals/lab_animals/legislation_en.htm">Directive 2010/63/EU</a> - to avoid unnecessary repetition of studies.</p> </div> </div> </div>


Data from patient registries to replace clinical trials in previously untreated haemophilia patients, , 30/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p> <img alt="Patient registries slider" class="file-default media-element" data-delta="3" height="480" src="https://www.ema.europa.eu/sites/default/files/patient_registries.png" style="height: 225px; width: 300px; margin: 20px; float: left;" typeof="foaf:Image" width="640" /> EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications for certain haemophilia medicines.</p> <p>The revision introduces an important change in relation to the investigation of recombinant and human plasma-derived factor VIII and factor IX haemophilia medicines in previously untreated patients: for this very small subset of haemophilia patients data should be collected from <a href="https://www.ema.europa.eu/en/human-regulatory/post-authorisation/patient-registries" target="_self">patient registries</a> rather than from small clinical trials, that may not be fully representative of how the medicine is used day-to-day once it’s on the market.</p> <p>This new approach relies on data from registries as a source of high-quality, real-world data to support regulatory decision-making. It reflects that in this subset of patients, clinical data are difficult to obtain as the subset is highly-selected and the numbers available for trials are very small.  </p> <p>The updated guidelines aim to optimise and facilitate the use of these registries and provide parameters for core data sets that should be collected.</p> <p>The new approach described in the haemophilia guidelines waiving the requirement for a clinical trial in previously untreated patients was discussed at an EMA <a href="https://www.ema.europa.eu/en/events/workshop-haemophilia-registries" target="_self">workshop on haemophilia registries in July 2015</a> where the use of registries in haemophilia was explored. Following a public consultation in 2017, a <a href="https://www.ema.europa.eu/en/events/haemophilia-registries-workshop" target="_self">second workshop on haemophilia registries was held on 8 June 2018</a> which aimed at defining the requirements for practical implementation using existing registries to support post-authorisation observational studies of haemophilia medicines. The workshop discussed <span class="file"> <img alt="PDF icon" class="file-icon" src="/sites/all/themes/ema/file_icons/application-pdf.svg" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/report/report-haemophilia-registries-workshop_en.pdf" target="_blank" type="application/pdf; length=639928">recommendations</a> </span> on important aspects such as appropriate governance of registries, patient consent, data collection, data quality and data sharing, and interoperability between different registries.</p> <p>The <a href="https://www.ema.europa.eu/en/clinical-investigation-recombinant-human-plasma-derived-factor-viii-products" target="_self">revised guideline for haemophilia medicines for factor VIII deficiency</a> was published in July 2018 and the <a href="https://www.ema.europa.eu/en/clinical-investigation-recombinant-human-plasma-derived-factor-ix-products" target="_self">revised guideline addressing medicines for factor IX deficiency</a> is published today.  </p> <p>More information on the practical implementation of the guideline is available in a <span class="file"> <img alt="PDF icon" class="file-icon" src="/sites/all/themes/ema/file_icons/application-pdf.svg" title="application/pdf" typeof="foaf:Image" /><a class="ecl-link" href="https://www.ema.europa.eu/documents/other/questions-answers-revision-guidelines-clinical-investigation-recombinant-human-plasma-derived-factor/chmp/bpwp/144533/2009-rev-2-fix-products-ema/chmp/bpwp/144552/2009-rev-2_en.pdf" target="_blank" type="application/pdf; length=140134">questions-and-answers document</a> </span> . EMA’s initiative on <a href="https://www.ema.europa.eu/en/human-regulatory/post-authorisation/patient-registries" target="_self">patient registries</a> is supported by a task force comprising representatives from its scientific committees and working parties, representatives from the European Commission and experts from national competent authorities.</p> </div> </div> </div>


Meeting highlights from EMA’s safety committee (PRAC) 26-29 November 2018, , 30/11/2018

<div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><p>At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of signals, risk management plans, periodic safety update reports and post-authorisation safety studies.</p> <p>The Committee did not start or conclude any referral procedures. More information on all safety reviews currently under evaluation is provided in the ‘Ongoing referrals’ table.</p> <p>Information on all topics discussed by the PRAC is available in the agenda below. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting in January.</p> </div> </div> </div> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="agenda-section" id="agenda-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Agenda</h3> </div> </div> </div> </div> <ul class="ema-listings"> <li class="ecl-list-item ema-list-item ema-list-item--file"> <a href="https://www.ema.europa.eu/documents/agenda/agenda-prac-draft-agenda-meeting-26-29-november-2018_en.pdf" target="_blank" class="ecl-link ecl-list-item__link"> <div class="ecl-u-sr-only">List item</div> <div class="ecl-list-item__body"> <div class="ecl-list-item__meta"> <svg class="ema-icon ema-list-item ema-list-item--file"> <use xlink:href="https://www.ema.europa.eu/sites/all/themes/ema/framework/images/icons/ema-icons.svg#ema-icon-set_pdf" /> </svg> </div> <h3 class="ecl-list-item__title ecl-heading"> Agenda - PRAC draft agenda of meeting 26-29 November 2018 <small class="ema-u-color-grey-2"> (PDF/659.37 KB) </small> </h3> <p class="ecl-list-item__detail ecl-paragraph"> <div class="ema-u-color-grey-2"> <small> Draft<br/> <br /> First published: 26/11/2018 <br/> EMA/PRAC/829194/2018 </small> </div> </p> <div class="ecl-list-item__action"></div> </div> </a> </li> </ul> , <div class="field field-label-hidden field-name-field-ema-parag-section-title field-type-text"> <a name="ongoing-referrals-section" id="ongoing-referrals-section"></a> <div class="ecl-u-mv-m"> <div class="ema-separator ema-u-bg-primary"> <div class="ema-separator__heading ema-u-bg-primary"> <h3 class="ema-separator__heading--title-primary ema-separator__heading--title ecl-heading ecl-heading--ema-h3">Ongoing referrals</h3> </div> </div> </div> </div> <div class="ecl-editor field field-label-hidden field-name-field-ne-body field-type-text-with-summary"> <div class="ecl-field__body"> <div class="ecl-editor first last"><table border="1" cellpadding="0" cellspacing="0" width="100%"><thead><tr><th style="background-color:rgb(227, 227, 227)"> <p>Procedure</p> </th> <th style="background-color:rgb(227, 227, 227)"> <p>Status</p> </th> <th style="background-color:rgb(227, 227, 227)"> <p>Update</p> </th> </tr></thead><tbody><tr><td style="background-color:rgb(255, 255, 255); vertical-align:top"> <p>Article-31 procedure: <a class="ecl-link" href="https://www.ema.europa.eu/en/medicines/human/referrals/methotrexate-containing-medicinal-products">Methotrexate containing medicinal products</a></p> </td> <td style="background-color:rgb(255, 255, 255); vertical-align:top"> <p>Under evaluation</p> </td> <td style="background-color:rgb(255, 255, 255); vertical-align:top"> <p>PRAC continued its assessment.</p> </td> </tr></tbody></table></div> </div> </div>


Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 December 2018, CVMP, 07/12/2018

CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for an initial marketing authorisation application...


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018, CHMP, 14/12/2018

EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2018 meeting. Two orphan medicines1 received a positive...


EMA Management Board: highlights of December 2018 meeting, , 14/12/2018

EMA’s Management Board heard an update from Deputy Executive Director Noël Wathion on the Agency’s preparations for 2019, a year of transition for EMA....


Responding to emerging health threats in the EU, , 17/12/2018

EMA has published a plan outlining how it would respond to an emerging cross-border threat to health, such as an influenza pandemic. The health...


European Medicines Agency closed 21 December 2018 to 2 January 2019, , 19/12/2018

EMA is closed from 18:30 on Thursday 20 December 2018 until 7:30 on Thursday 3 January 2019. Outside of working hours and on public holidays, it is...


Regulatory Science to 2025 – launch of six-month public consultation, , 19/12/2018

EMA has published its draft  ‘Regulatory Science to 2025’ strategy for a six-month public consultation . This is a proposed plan for advancing the...


Human medicines: highlights of 2018, , 04/01/2019

EMA has published an overview of its key recommendations of 2018  on the authorisation and safety monitoring of medicines for human use. New...


Veterinary medicines: highlights of 2018, , 04/01/2019

EMA has published an overview of its key recommendations of 2018  regarding the authorisation and safety monitoring of veterinary medicines. In...


Revised guideline aims to strengthen global approach to development of new antibacterial medicines, , 14/01/2019

EMA has published a revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections for a six-...


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019, CHMP, 18/01/2019

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of...


EMA relocation updates , , 23/01/2019

The European Medicines Agency (EMA) will physically relocate to the Netherlands in early March 2019. The Dutch authorities have already officially handed...


No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life, CHMP, 23/01/2019

Preliminary results from the ANNOUNCE study1 show that Lartruvo (olaratumab) in combination with doxorubicin is not more effective at prolonging the...