European Medicines Agency
EU agency coordinating scientific evaluation and GMP/GVP guidance across member-state authorities.
WHAT EMA COVERS
The European Medicines Agency is the EU’s scientific agency for human and veterinary medicines. It coordinates evaluation and safety monitoring across the Union, most visibly through the centralised authorisation procedure that produces a single marketing authorisation valid in all member states. Its scientific committees — CHMP for human medicines, PRAC for pharmacovigilance risk, CVMP for veterinary — do the assessment work.
WHERE IT SITS INTERNATIONALLY
EMA is an ICH member, and EU authorities are founding participants in PIC/S. The EU-US Mutual Recognition Agreement allows reliance on each other’s GMP inspections for many human medicines, reducing duplicate inspection of the same site.
HOW ITS REQUIREMENTS BITE
EMA is a coordinating agency, not an inspectorate: GMP and GCP inspections are performed by the national competent authorities of the member states, and EMA coordinates them, maintains the shared EudraGMDP database of certificates and non-compliance reports, and manages EudraVigilance for safety data. Legal decisions on centralised authorisations are taken by the European Commission on EMA’s scientific opinion.
WHAT EMA PUBLISHES
- 01Scientific guidelines and reflection papers for human and veterinary medicines
- 02Good Pharmacovigilance Practices (GVP) Modules I–XVI
- 03European Public Assessment Reports (EPARs) for authorised products
- 04EudraGMDP entries — GMP/GDP certificates and non-compliance reports
- 05Q&A documents that often carry the practical detail behind a guideline
WHAT PRACTITIONERS GET WRONG
- ›EMA does not inspect — member-state authorities do; a "EMA inspection" is really a national inspection coordinated through EMA.
- ›EMA gives a scientific opinion; the legally binding decision on a centralised authorisation is the European Commission’s.
- ›GMP text itself is published by the Commission in EudraLex Volume 4, not by EMA.
- ›EudraGMDP is the public record of who holds a valid GMP certificate — and who has a non-compliance report.
EMA STANDARDS SPEQ DECODES · 6
DISCIPLINES IN EMA’S REMIT
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