베레젠 및 플리작 허가를 바탕으로 한 2016년 미국 FDA 식물의약품 가이드라인에 대한 고찰

초록

Botanical products derived from plants have been used for a long time. In the early 2000s, regulation authorities implemented development guidelines for botanical drugs. In US, two botanical drugs, Veregen and Fulizaq, were approved and have been sold in global markets. US Food and Drug Administration (FDA) revised their botanical drug development guideline for industry in 2016 based on the experiences of reviewing botanical New Drug Applications (NDAs) and Investigational New Drug applications (INDs). General approach to botanical drug development has remained unchanged (marketing of botanicals under NDAs, botanical drug development under INDs, INDs for Phase I, II, and III clinical studies) compared to 2004 versions. However, a number of specific recommendations have been modified and several new sections like ‘NDAs for botanical drug products’ have been added especially for late phase development and NDA submission. For local pharmaceutical companies that are developing botanical drugs for worldwide markets, we summarize herein the major issues for the newly updated US FDA botanical guideline based on the review materials of the previously approved two botanical drugs.

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