在美国进行植物药开发的路径、要求及策略探讨

近年来,越来越多药企开始在美国进行植物药的临床试验申请和新药申报,美国 FDA 日益重视植物药的开发,于 2016 年 12 月 发布并实施了修订版的《行业指南:植物药》,为植物药后期开发提供更多专业建议。结合 FDA 已经批准的 2 个植物药案例,详细介绍 植物药 CMC(化学、生产、控制)、临床前研究和过往人用历史方面的基本要求,浅谈 FDA 的申报要求、审评思想和申报策略,以期 为中国中药企业的国际化开发和注册提供参考。

Discussions on the Paths, Requirements and Strategies for Botanical Drug Development in the United States

With a growing number of investigational new drug (IND) and new drug application (NDA) of botanical drugs in the United States, FDA has placed an increased emphasis on the development of botanical drugs. In December 2016, FDA released and implemented the revised Botanical Drug Development: Guidance for Industry to provide more professional suggestions for the late-stage development of botanical drugs. With two case studies of botanical drugs approved by the FDA, this paper elaborates basic requirements of CMC (chemistry, manufacturing and control), pre-clinical studies and previous experience on human use of botanical drugs to tentatively analyze the submission requirements, strategies and review thought of the FDA, so as to provide reference for the internationalization of drug development and registration by Chinese traditional medicines enterprises.