European Medicines Agency

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU). It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines.

EMA protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective, and of high quality. EMA serves a community of around 450 million people living in the EU, and has been operating since 1995.

• Authorisation of medicines

EMA's role in the centralised authorisation procedure for medicines marketed in the EU. Summary of the national authorisation procedure

• Crisis preparedness and management

EMA's role in preparing for and managing crisis situations affecting the EU's single market for medicines and medical devices

• Legal framework

An explainer of the principles governing the placing of medicines on the EU's single market

• Regulatory science research

How EMA supports innovation and ensures availability of medicines for human and veterinary use