The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are organising a joint workshop on 25 September 2026 to discuss regulatory perspectives on herbal medicinal and botanical drug product development. The hybrid event, hosted at EMA's Amsterdam headquarters from 10:00 to 13:00 CEST, aims to facilitate development of these products as regulated medicines amid growing public interest in their therapeutic potential.
The workshop, titled "Regulatory Perspectives on Herbal Medicinal / Botanical Drug Product Development," will be co-chaired by Marta Sokolowska, Deputy Center Director of Substance Use and Behavioral Health at FDA's Center for Drug Evaluation and Research, and Steffen Thirstrup, Chief Medical Officer of EMA. The agenda includes opening remarks, a session on public health need for treatment and regulation, a comparative overview of EMA and FDA regulatory frameworks, a panel discussion, and a wrap-up.
According to the event description, both regulators have existing guidance to support development of these complex products, but meaningful differences exist in their respective frameworks. The workshop is designed to advance shared understanding and support pharmaceutical developers navigating the evolving regulatory landscape.
No prior coverage of this event exists in recent months. The workshop is scheduled for 25 September 2026, with registration details to be announced separately.
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