The American Herbal Pharmacopoeia®

AHP News & Views

FDA to convene a joint workshop with the European Medicines Agency (EMA) on September 25, 2026 to discuss regulatory considerations for herbal medicinal/botanical drug products intended for medicinal use

Dear Friends of AHP,



This is very short notice for a very important subject that we may or may not be able to access. This workshop, interestingly hosted by EMA in Amsterdam, is specifically designed to discuss the development of the botanical drug model in the US. If it is accessible, US participants will have to tune in from 4-7 am ET. Our attempt to register for the event was unsuccessful, suggesting it may be closed to those not invited.


The registration page is here: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-perspectives-herbal-medicinalbotanical-drug-product-development-joint-fdaema-workshop?utm_medium=email&utm_source=govdelivery


The agenda is posted here: https://www.ema.europa.eu/en/documents/agenda/agenda-regulatory-perspectives-herbal-medicinal-botanical-drug-product-development-joint-fda-ema-workshop_en.pdf


In addition to FDA and EMA representatives, Dr Stefan Gafner of the American Botanical Council and Dr Holly Johnson of the American Herbal Products Association, among others, will be participating.


This workshop comes after the introduction of House of Representative Bill 10150 Advancing Botanical Drug Development Act of 2026 and a Federal Register notification from FDA seeking stakeholder comments regarding the botanical drug model. AHP will discuss both of these initiatives in a follow-up communication. If you can get into the workshop, please let us know the primary discussion points.


For more information about AHP, or if you are interested in becoming an AHP member, please visit herbal-ahp.org. Be sure to follow us on LinkedIn at https://www.linkedin.com/company/herbal-ahp.

 

Sincere regards,

Roy Upton, RH, DipAyu

President, American Herbal Pharmacopoeia®

 

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American Herbal Pharmacopoeia | PO Box 66809 | Scotts Valley, CA 95067 US