FDA and EMA Share Global Leadership in Drug Regulatory Processes
1 report, 1 independent
Updated Sep 21
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What happened
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have shared the global regulatory leadership mantle. This discussion followed a U.K. MHRA Scientific Advice Meeting regarding a confirmatory Phase 3 trial. The leadership sharing is linked to Project Orbis, through which the FDA has approved products from the U.K. leadership.
From intelligencer.ca
Why it matters
The leadership sharing impacts the global standards for drug approval. This process is relevant to companies seeking market authorization for products in both the U.S. and the European Union.
Both the FDA and the EMA govern drug approval processes.
From intelligencer.ca
Who's involved
- FDAU.S. regulatory agency involved in global drug approval standards
- European Medicines AgencyHighest regulatory authority on medicines in the European Union
- companyLegal entity involved in the leadership sharing via Project Orbis
Possible ripples
Who this could reach next, traced step by step from the reporting. Possibilities worth considering, not forecasts.Keep exploring
The entities involved
- FDA
-
European Medicines Agency
highest regulatory authority on medicines in the European Union
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