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EMA

 •  December 21, 2017

Thoughts on 2017 and challenges for 2018​As we approach the end of 2017 I would like to take a moment to thank all our partners and stakeholders for their support during this year. It was not always easy to stay focused on our core tasks with the uncertainty of relocation hanging over us, nonetheless we did everything we could to deliver on EMA’s...

EMA

 •  December 21, 2017

Pharmacovigilance fees expected to increase by 1.4%The European Medicines Agency reminds applicants and marketing authorisation holders that adjusted fees for pharmacovigilance applications are expected to come into effect in mid-January 2018.The European Commission adopted a regulation adjusting the pharmacovigilance fees payable to the Agency on...

EMA

 •  December 17, 2017

Brexit update and adoption of work programme and budget for 2018Update on Brexit preparationsThe Management Board of the European Medicines Agency (EMA) heard from Executive Director Guido Rasi and Deputy Executive Director Noël Wathion how the Agency is preparing for relocation to Amsterdam in the Netherlands, and operationally for the United...

EMA

 •  December 1, 2017

EMA and European Commission publish updated Q&AsThe European Medicines Agency (EMA) and the European Commission have published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union (EU).Companies are reminded to plan in advance for the situation that the United Kingdom (UK) will...

EMA

 •  December 1, 2017

SummaryThis 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...

EMA

 •  December 1, 2017

Title Committee for Advanced Therapies (CAT): 6-8 December 2017 Date 06/12/2017 - 08/12/2017 Location European Medicines Agency, London, UK Summary The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines.

EMA

 •  November 28, 2017

Additional guidance relates to medicines for human and veterinary useThe European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU).The guidance document outlines the practical and simplified requirements that companies should...

EMA

 •  November 24, 2017

Adaptations ensure a high level of quality for ATMPs and patient protectionThe European Commission has published a set of guidelines on good manufacturing practice (GMP) specific to advanced therapy medicinal products (ATMPs).ATMPs are medicines for human use that are based on genes or cells. These therapies offer ground-breaking new opportunities...

EMA

 •  November 22, 2017

Better safety monitoring for patients across EuropeThe European Medicines Agency (EMA) has launched today a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new system makes it...

EMA

 •  November 7, 2017

Close collaboration with new host country as of day one key for successful moveWith less than two weeks to go before EU Member States select a new host city for the European Medicines Agency (EMA) on 20 November 2017, the Agency prepares itself to immediately start working with the new host country. As of that date, the Agency has less than 17...