HomeInsights
INDUSTRY:
Pharma
TOPIC:
Regulatory & Legal, Products & Services, Business & People, Manufacturers & Providers
TITLE:
EMA: Revising the guideline on first-in-human clinical trials
BRIEF:
The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. Comments should be sent to FIH-rev@ema.europa.eu using the template provided.
LEGAL IMPLICATIONS:
BUSINESS IMPLICATIONS:
