Monterey, California, U.S. / Amsterdam, Netherlands, September 28, 2026
BRC Therapeutics has participated in a joint regulatory workshop convened by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to discuss the future of botanical drug development. The company announced that Dr. Catherine Maher, BRC’s Head of Regulatory Affairs, represented the clinical-stage pharmaceutical company at the Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development workshop in Amsterdam, Netherlands. The meeting brought together regulators and drug developers to examine regulatory considerations for botanical medicines intended for therapeutic use. For BRC, participation represents an opportunity to engage in discussions surrounding the development of FDA-regulated, prescription-grade botanical therapeutics and evolving regulatory approaches for this emerging pharmaceutical field.
FDA and EMA Examine Botanical Drug Regulation
The workshop comes as regulatory agencies continue examining how botanical products can be developed and evaluated as pharmaceutical medicines. According to BRC, the FDA recently issued a Request for Information seeking public and industry input on opportunities to advance botanical drug products, while the FDA’s Center for Drug Evaluation and Research has also participated in discussions on botanical drug development. BRC submitted a contribution to the FDA’s request and subsequently participated in the Amsterdam workshop. These activities highlight ongoing discussions around how developers can navigate scientific, manufacturing and regulatory requirements when advancing complex botanical products toward clinical use. Botanical drug development can present distinctive challenges because products derived from plants may contain multiple active constituents rather than a single conventional small-molecule pharmaceutical ingredient. For developers, establishing consistent composition, manufacturing controls, quality specifications, safety and clinical evidence is therefore an important component of pharmaceutical development. BRC says its approach combines botanically derived cannabinoids with defined and proprietary ratios and subjects its investigational products to FDA regulatory requirements.
BRC Advances Prescription Cannabinoid Therapeutics
BRC Therapeutics is a clinical-stage pharmaceutical company developing multimodal cannabinoid therapeutics for neurological, inflammatory and pain-related conditions. The company’s pipeline includes investigational prescription medicines containing cannabinoids at defined ratios. Two of its programs are currently being evaluated in clinical trials for Complex Regional Pain Syndrome (CRPS) and Aromatase Inhibitor-Induced Arthralgia (AIIA). One of the company’s leading programs, BRC-002, is an investigational botanical cannabinoid therapeutic being developed for CRPS. The candidate received FDA Orphan Drug Designation in December 2024, and the FDA cleared its IND application in April 2026, allowing BRC to proceed with a Phase I study in healthy volunteers. BRC describes BRC-002 as a multimodal botanical drug composed of prescription-grade cannabinoids at defined and proprietary ratios. The company’s development model emphasizes the application of pharmaceutical-quality controls to botanically derived medicines. BRC has reported capabilities spanning drug discovery, clinical development, manufacturing and regulatory compliance, including DEA registrations supporting research, development and manufacturing activities involving controlled substances. Its stated objective is to develop predictable, standardized cannabinoid medicines through regulated pharmaceutical pathways rather than relying on unstandardized botanical products.
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Regulatory Dialogue Could Shape Future Development
BRC’s participation in the FDA–EMA workshop comes at an important stage for the broader botanical medicine sector. The company says greater regulatory clarity could help developers understand expectations for advancing botanical products from laboratory research through clinical trials and potential marketing authorization. However, participation in a regulatory workshop does not represent an FDA or EMA endorsement of BRC’s products, and the company’s investigational medicines remain subject to the normal requirements for clinical development and regulatory review.
For the pharmaceutical industry, continued dialogue between regulators and developers could help define approaches for evaluating botanical drug quality, manufacturing consistency, safety and clinical efficacy. BRC’s involvement also demonstrates how clinical-stage companies developing cannabinoid-based medicines are engaging with regulators as the scientific and regulatory framework for botanical pharmaceuticals evolves. As BRC continues clinical development of its investigational programs, the company says it expects further engagement with both agencies as discussions around botanical drug regulation progress.
Source: BRC Therapeutics press release
