European Medicines Agency (EMA)
The EU agency that evaluates and supervises medicines.
Overview
The EMA assesses applications for EU-wide marketing authorisation, which the Commission then grants, and coordinates pharmacovigilance and inspections.
Its powers include supervising and examining the organisations it oversees and publishing standards that others adopt.
In the European Union it works at supranational level. Instruments connected to it in this glossary include EMA requirements.
Check the official sources below for legal scope, applicable dates and exceptions. This entry is an explanatory reference, not legal advice.
Why it matters
Its examinations and expectations often decide outcomes more than the text of the law.
Who it affects
Organisations in pharmaceuticals in the European Union.
Where it sits
Ten linked steps connect where you operate to the proof that you complied.
- 01Jurisdiction
- 02Industry
- 03Activity
- 04Authority
- 05Regulation
- 06Requirement
- 07Guidance
- 08Control
- 09Evidence
- 10Enforcement
Connections
The terms most closely tied to EMA. Select one to open it.
What to do about it
- 1Confirm whether EMA has power over you, and through which licence, registration, membership or activity.
- 2Follow its rules, guidance and enforcement publications as they are issued.
- 3Map each obligation it creates to a control with a named owner.
- 4Keep examination-ready evidence for its highest-risk obligations.
From requirement to evidence.
Regulation Layer tracks its publications in the change feed, maps its obligations to your controls.
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