摘要 本文检索近十年中成药上市后进行的临床研究，尤其是在SCI杂志上发表的高质量临床研究，回顾目前注册中成药中进行上市后再评价现状及与国际接轨的情况。列出目前中成药进入国际市场存在的问题，并以FDA、加拿大及欧盟对于植物药及草药的注册要求来详细陈述，指出中成药上市后再评价的必要性及未来的发展趋势。

    关键词 中成药；上市后再评价；注册制度

    Abstract This study has reviewed the post market clinical trials of Proprietary Chinese Medicine， especially those which have published high quality SCI papers to assess the current situation and challenges faced in this area. At the same time， we also listed the registration differences between Food and Drug Administration (FDA) ......