European Medicines Agency (EMA)

Overview

• Role: EMA guarantees the scientific evaluation, supervision & safety monitoring of human & veterinary medicines in the EU.
• Executive Director: Emer Cooke
• Established in: 1995
• Number of staff: 897
• Location: Amsterdam (the Netherlands)
• Website: EMA

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).

What it does

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:

• facilitating the development of medicines & access to them
• evaluating applications for marketing authorisations
• monitoring the safety of medicines throughout their lifecycle
• providing information to healthcare professionals & patients

Who benefits

The EMA's work benefits:

• patients
• healthcare professionals
• academics
• pharmaceutical companies
• medicine developers
• health policymakers

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.

Further information

Regulatory information on human medicines

Regulatory information on veterinary medicines

Partners & networks

Publications

Careers