Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development – Joint FDA/EMA Workshop September 25, 2026

Workshop | Mixed

• Date: September 25, 2026
• Time: 4:00 a.m. - 7:00 a.m. ET

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Attend

Register for This Event

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Attend in Person or Virtual

Virtual: via European Medicines Agency (EMA)

In Person: 
European Medicines Agency 
Domenico Scarlattilaan 6 
1083 HS Amsterdam 
The Netherlands

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Public interest in the therapeutic potential of herbal medicinal/botanical drug products continues to grow, driving increased efforts to develop such products as regulated medicinal products. Recognizing both the promise of these complex products and the unique challenges they pose, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have existing guidance to facilitate their development. While both regulators share core principles, there are meaningful differences in their respective regulatory frameworks.

To advance shared understanding and support pharmaceutical developers navigating this evolving landscape, we are organizing a workshop offering a practical exploration of regulatory considerations for herbal medicinal/botanical drug products intended for medicinal use.

The EMA has further information on the workshop, including agenda and location of workshop recording once available.