EMA requirements
EU requirements for medicines coordinated by the European Medicines Agency, covering authorisation, pharmacovigilance and clinical trials.
Overview
EU pharmaceutical law, with EMA scientific guidelines, governs centralised marketing authorisation, good manufacturing and clinical practice, the Clinical Trials Regulation and pharmacovigilance.
As regulation it is binding and specific, and it is the layer most directly mapped to controls. The authorities most closely connected to it are EMA.
Check the official sources below for legal scope, applicable dates and exceptions. This entry is an explanatory reference, not legal advice.
Why it matters
They decide access to the EU medicines market.
Who it affects
Pharmaceutical companies and sponsors of EU clinical trials.
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 requirements. Select one to open it.
What to do about it
- 1Confirm whether you are in scope: who it covers, which activities and where.
- 2Break it into testable requirements.
- 3Map each requirement to a control and an owner.
- 4Track amendments, implementing rules and guidance.
- 5Keep sealed evidence for every control run.
From requirement to evidence.
EMA requirements are mapped alongside FDA and Health Canada for global programmes.
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