The US Food and Drug Administration (FDA) has issued draft guidance, Botanical Drug Development, to describe the Center for Drug Evaluation and Research’s current thinking on appropriate development plans for botanical drugs to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 In addition, the draft guidance provides general information on the over-the-counter drug monograph system for botanical drugs.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, many scientific principles described in this guidance may also apply to these products, according to the FDA.
The draft guidance specifically discusses several areas in which, due to the unique nature of botanical drugs where the agency finds it appropriate to apply regulatory policies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 Because the draft guidance focuses on considerations unique to botanical drugs, policies and recommendations applicable to both botanical and nonbotanical drugs are generally not covered in the guidance; the FDA advises readers to refer to other FDA guidance documents for the appropriate information.
The draft guidance revises the Guidance for Industry on Botanical Drug Products issued in June 2004. After it has been finalized, thie draft guidance will replace the June 2004 guidance. The FDA notes in its draft guidance that the general approach to botanical drug development has remained unchanged since that time; however, based on improved understanding of botanical drugs and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.