随着全球疾病谱的变化和人类的健康需求，如何保证源源不断的创新药研发和上市的可持续性，是当今国内外医药界普遍面临的棘手问题。近年来，美、欧和加拿大等西方国家陆续对植物药的管理法规进行了灵活调整，在认可植物药与非植物药具有等同地位的同时，也在一定程度上放宽了产品审批和上市的技术要求。简要分析欧美国家中药植物药监管法规的变化，以我国中药国际化的第一个示范品种复方丹参滴丸的申请为例，对其从1997年首次取得美国FDA的IND以来，进行的一系列后续研究以及美国II期临床研究的全过程进行系统总结和回顾，探讨与美国FDA沟通的最新经验和体会，对中药未来的国际研发提出新的展望。

With the global changes of the disease spectrum and the needs of health, it is now the knotty problem and huge challenge for the pharmaceutical industries to ensure the continuous R&D and the sustainability of market for the innovative drugs worldwide. In recent years, US, EP, and Canada issued the new regulations on the phytomedicine, which not only means they will have the equal status compared to the non-botanical drugs, but also more flexibility on the regulations of the approval and launch on the market. In this paper, the different regulations of phytomedicine and botanical products in the US, EP and Canada are introduced, the process of the series of R&D of Dantonic (Fufang Danshen Dripping Pill, the 1^st CMM compound drug with the FDA IND approval) and its global Phase II clinical trial since 1997 reviewed, the experiences on the regulatory conversation with FDA summarized, and the new prospect on the future global R&D of chinese materia medica put forward.