EMA
The EU regulatory agency that authorises and supervises medicines for use across member states.
Definition
The European Medicines Agency (EMA), based in Amsterdam, is the EU's scientific medicines regulator. It evaluates Marketing Authorisation Applications under the centralised procedure (mandatory for biologics, orphan drugs, oncology, and certain therapeutic areas), issues CHMP opinions, and publishes European Public Assessment Reports (EPARs). National regulators (BfArM, ANSM, AEMPS, AIFA) handle some products via the decentralised procedure.
See also
- CHMP — The EMA committee that issues opinions on whether a medicine should be authorised in the EU.
- EPAR — The publicly available EMA assessment of a centrally-authorised medicine.