FDA Announces September 25 Joint Workshop With European Medicines Agency on Botanical Drug Product Development Regulations
The U.S. Food and Drug Administration confirmed via press announcement Friday September 4, 2026 that it will convene a joint workshop with the European Medicines Agency (EMA) on Friday September 25, 2026 to discuss regulatory considerations for herbal medicinal and botanical drug products intended for medicinal use. The workshop follows the FDA's ongoing public-input process on botanical drug development that generated substantial biotech and pharmaceutical industry commentary earlier in 2026. Botanical drugs occupy an underdeveloped regulatory category in the U.S. — FDA has approved only two botanical drugs to date (Veregen sinecatechins from green tea for genital warts, approved 2006; Fulyzaq crofelemer from Croton lechleri sap for HIV-related diarrhea, approved 2012). Proposed legislation in the U.S. would extend 12-year market exclusivity to FDA-approved botanical drugs, matching the biologics exclusivity framework. The Sept 25 workshop matters for the peptide-industry pipeline because plant-derived and marine-organism-derived peptide products (defensins, ranatuerin analogs, plant-defensin-based antimicrobials) occupy a similar regulatory gray zone between conventional pharmaceuticals and dietary supplements.