Medicines regulation in the European Union

A network, not a single office

Medicines regulation in the European Union runs as a network: the European Medicines Agency (EMA) coordinates the scientific work, the European Commission issues legally binding decisions, and the national competent authorities of the member states do much of the assessment and inspection. This structure is known as the European medicines regulatory network.

Routes to authorisation

A medicine can be authorised for the whole EU through the centralised procedure, with one EMA scientific evaluation leading to a single European Commission marketing authorisation valid in all member states; this route is mandatory for many innovative products, including most biotechnology medicines. Other products use national or mutual-recognition routes involving individual member states.

Clinical trials are authorised and supervised through a common EU framework with a shared application portal, and medical devices follow the EU Medical Device Regulation, which relies on designated notified bodies for conformity assessment of most devices.

Public records and registries

Every centrally authorised medicine has a public European public assessment report (EPAR) with the product information and the scientific basis of the decision. The EudraVigilance system collects suspected adverse reactions, with public summary access through adrreports.eu. Clinical trials appear in the EU Clinical Trials Information System (CTIS).

Using this profile

This is a structural orientation, not legal or regulatory advice. EU procedures and the device transition timelines change; anyone acting on a real submission should work from the network's current guidance or a qualified regulatory professional.