This guidance describes the Center for Drug Evaluation and Research’s (CDER’s) current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products.

This guidance specifically discusses several areas in which, due to the unique nature of botanical drugs, the Agency finds it appropriate to apply regulatory policies that differ from those applied to nonbotanical drugs, such as synthetic, semi-synthetic, or otherwise highly purified or chemically modified drugs, including antibiotics derived from microorganisms. Because this guidance focuses on considerations unique to botanical drugs, policies and recommendations applicable to both botanical and nonbotanical drugs are generally not covered in this document; readers should refer to other FDA guidance documents for appropriate information.

This guidance replaces the Guidance for Industry on Botanical Drug Products issued in June 2004. The general approach to botanical drug development has remained unchanged since that time; however, based on improved understanding of botanical drugs and experience acquired in the reviews of NDAs and INDs for these drugs, specific recommendations have been modified and new sections have been added to better address late-phase development and NDA submission for botanical drugs.

Posted on the FDA website on 28 December 2016