Understanding EMA’s Role in Clinical Trial Authorization
Understanding EMA’s Role in Clinical Trial Authorization How the EMA Supports and Coordinates Clinical Trial Authorizations in the EU The European Medicines Agency (EMA) plays a critical role in the harmonized framework for clinical trial authorization across the European Union (EU). Under Regulation (EU) No. 536/2014—commonly known as the Clinical Trial Regulation (CTR)—the EMA has…
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