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EMA

EU-Specific

European Medicines Agency — EU regulatory body approving medicines for the EU market.

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Sources

  1. European Medicines Agency — What we do ema.europa.eu accessed 23 September 2026

The EMA says it “fosters scientific excellence in the evaluation and supervision of medicines”, and that its evaluations of applications through the centralised procedure “provide the basis for the authorisation of medicines in Europe”. Crucially, the agency does not grant the authorisation: “the legal decision to grant, suspend or revoke a marketing authorisation” for centrally authorised medicines “falls under the remit of the European Commission”. EMA assesses; the Commission decides.

The EMA’s own description. National procedures outside the centralised route are not covered here.

Related terms

From the AJG lexicon archive (July 2026).

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