European Medicines Agency – 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).

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

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.

Regulatory information on human medicines

Regulatory information on veterinary medicines

Partners & networks