EMA list of national competent authorities in the EU

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  • Regulatory and ethics bodies

The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for medicinal products for human use. This EMA webpage provides a consolidated, regularly updated directory of national competent authorities for human medicines across the European Union and European Economic Area. The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not fall under the scope of the centralised procedure. They may also be responsible for other activities related to medicinal products, such as authorisation of clinical trials.They also supply thousands of European experts who serve as members of EMA's scientific committees, working parties or in assessment teams supporting their members.It supports coordination within the European medicines regulatory network by making it easy to find the responsible authority and its main contact details for each Member State. This EMA directory helps research teams quickly find the right national authority for clinical trial authorisations and safety reporting, access up‑to‑date national guidance and contact details, and efficiently plan multi‑country research by directing regulatory queries to the appropriate body in each participating state.