The European Medicines Agency (EMA) protects and promotes human and animal health by evaluating and monitoring medicines within the European Union (EU) and the European Economic Area (EEA).
The Agency's main responsibilities are authorising and monitoring medicines in the EU. Companies apply to it for a single marketing authorisation, which is issued by the European Commission. If granted, this enables them to market the medicine concerned throughout the EU and the EEA. Given the wide-ranging scope of the centralised procedure, most genuinely innovative medicines marketed in Europe are authorised by the EMA.
The Agency fulfils its responsibilities by:
The EMA is governed by a 36-member Management Board. Members are appointed to act in the public interest and do not represent any government, organisation or sector. The Board sets the Agency's budget and approves its annual work programme. The Agency's Executive Director is responsible for all operational matters, staffing issues and drawing up the annual work programme. The EMA has 7 scientific committees and several working parties, involving thousands of experts from across Europe.
The EMA cooperates closely with national regulatory authorities in EU countries and with the Commission's Directorate-General for Health in a partnership known as the European medicines regulatory network. It also interacts with patients, healthcare professionals and academia. Finally, it also works together with its sister agencies, particularly the European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA).
The EMA works independently, openly and transparently and upholds the highest standards in its scientific recommendations. Its scientific committees provide independent recommendations on medicines for human and veterinary use, based on a comprehensive scientific evaluation of data. The Agency publishes clear and impartial information about medicines and their approved uses.
The EMA's work benefits:
Through its scientific guidelines, scientific advice programme and incentives, it facilitates research into new medicines and encourages development, thereby translating progress in medical science into medicines with real health benefits for patients. In particular, it promotes the development of medicines for children and drugs to tackle rare diseases.