Regulatory Perspectives on Herbal Medicinal / Botanical Drug Product Development: Joint FDA / EMA Workshop

• Date:
  Vineri, 25 septembrie 2026 , 10:00 - 13:00 Amsterdam time (CEST)
• Locație:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

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.

Recognising 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 organising a workshop offering a practical exploration of regulatory considerations for herbal medicinal / botanical drug products intended for medicinal use.

Registration

This is a hybrid meeting, with presence online and onsite.

Register via the link below:

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

Agenda

Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA Workshop: Event agenda