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Differences with European (EMA) and American (FDA) regulations

Abstract :

European Medicines Agency (EMA) and the U.S.


EMA vs. FDA: Key Regulatory Differences in Herbal Medicines Unveiled by Padideh Giah

A recent analysis by Padideh Giah Tech Development Center highlights crucial differences between the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in their regulatory approaches to herbal medicines.

While EMA allows traditional use registration based on documented history, the FDA requires rigorous clinical evidence and strict manufacturing controls. This insight can guide Iranian herbal startups in planning for international expansion and meeting regulatory expectations in different markets.

The full report will soon be available in Arabic, Chinese, and Persian.