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What does it take to turn a botanical extract into a prescription medicine? A plant may have a long history of medicinal use, but developers must still demonstrate consistent quality and reliable clinical benefit. In September 2026, those challenges became the focus of an FDA request for public input and a joint workshop with the European Medicines Agency in Amsterdam, bringing fresh attention to the path from botanical research to prescription treatment.

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On September 3, the FDA announced a Request for Information under Docket No. FDA-2026-N-9550, inviting researchers, clinicians, manufacturers, and other stakeholders to explain where botanical drug development encounters obstacles. The agency sought feedback to inform a potential update to its 2016 Botanical Drug Development guidance, alongside a roundtable with the Reagan-Udall Foundation. Questions covered product identity, potency, batch consistency, clinical trial design, and the potential contribution of real-world evidence. FDA announcement

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The discussion moved across the Atlantic on September 25, when the FDA and EMA co-hosted a public workshop at EMA headquarters in Amsterdam, with online participation. Co-chaired by the FDA’s Marta Sokolowska and the EMA’s Steffen Thirstrup, the workshop compared U.S. and European approaches to herbal medicinal products and botanical drugs. Participants examined the characterization of botanical active ingredients, manufacturing and quality documentation, and the evaluation of manufacturing changes after approval. For developers pursuing both markets, clearer expectations could help them plan studies and prepare regulatory submissions. Joint workshop agenda

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The FDA lists sinecatechins, crofelemer, and birch triterpenes as products approved through New Drug Applications, while anacaulase-bcdb received approval through a Biologics License Application. Each represents a botanical product that completed the applicable approval process. Ingredients such as psyllium and witch hazel also appear in certain over-the-counter drug monographs, providing another established route for specific botanical uses. FDA botanical drug products overview

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The public comment period closed on November 3, 2026, with 122 reported submissions. Together, the public request and the Amsterdam workshop gave developers opportunities to explain practical barriers while allowing regulators to compare their expectations. The next step is translating those discussions into guidance that helps development teams make decisions earlier, including which batches to study, what evidence to collect, and how that evidence might support submissions in both markets. Federal Register notice