European Medicines Agency
EU agency coordinating scientific evaluation and GMP/GVP guidance across member-state authorities.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
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.
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
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 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.
What an inspection under this authority actually probes
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.
EMA STANDARDS SPEQ DECODES · 11
DISCIPLINES IN EMA’S REMIT
EMA: frequently asked questions
Reference answers on European Medicines Agency’s mandate, what it publishes, and how its requirements acquire force.
Does the EMA inspect manufacturers?
No. EMA is a coordinating agency, not an inspectorate. GMP and GCP inspections are performed by the national competent authorities of the member states; EMA coordinates them and maintains the shared EudraGMDP database of certificates and non-compliance reports. An "EMA inspection" is really a national inspection coordinated through EMA.
Who takes the legal decision on a centralised marketing authorisation?
EMA gives a scientific opinion through committees such as the CHMP; the legally binding decision on a centralised authorisation is taken by the European Commission on that opinion. The result is a single marketing authorisation valid in all EU member states.
Where is EU GMP text published?
Not by EMA. GMP text itself is published by the European Commission in EudraLex Volume 4. EMA publishes scientific guidelines, Good Pharmacovigilance Practices modules, European Public Assessment Reports, and EudraGMDP entries.