EMA: The European regulatory system for medicines and the European Medicines Agency - A consistent approach to medicines regulation across the European Union

This booklet is intended to explain how the European regulatory system for medicines operates. It describes how medicines are authorised and monitored in the European Union (EU) and how the European medicines regulatory network – a partnership between the European Commission, the 50 medicines regulatory authorities in the EU and the European Economic Area (EEA), and the European Medicines Agency (EMA) – works to ensure that patients in the EU have access to safe and efficacious medicines.