本文以2006年10月在FDA获得批准的处方药VeregenTM的商品说明书为切入点,详细分析了作为植物药的VeregenTM在FDA审批过程中的一些关键点。中药走向世界是个漫长而艰苦的过程,但VeregenTM的例子证明,中药作为植物药在FDA注册成功不是不可能的。本文的分析与建议希望能为中药敲开FDA大门提供些许有价值的参考,给准备走向国际市场的国内中药制药企业一些有益的指导。

FDA approved on Oct. 2006 VeregenTM,the first botanical drug endorsed by the agency.This paper analyzes the key points that constitute the basis of FDA approving a botanical drug like VeregenTM.The product has a labeling strictly following the regulatory requirements,together with regulatory guidance references. Traditional Chinese Medicine （TCM）has a long way to go before becoming a globalized product. Fortunately, VeregenTM has let us to see some lights for more TCM products entering international markets. The analysis and suggestions given in this paper has offered valuable points to the domestic TCM pharmaceuticals that are interested in TCM products export.