隨著全球疾病譜的變化和人類的健康需求，如何保證源源不斷的創(chuàng)新藥研發(fā)和上市的可持續(xù)性，是當(dāng)今國內(nèi)外醫(yī)藥界普遍面臨的棘手問題。近年來，美、歐和加拿大等西方國家陸續(xù)對植物藥的管理法規(guī)進行了靈活調(diào)整，在認可植物藥與非植物藥具有等同地位的同時，也在一定程度上放寬了產(chǎn)品審批和上市的技術(shù)要求。簡要分析歐美國家中藥植物藥監(jiān)管法規(guī)的變化，以我國中藥國際化的第一個示范品種復(fù)方丹參滴丸的申請為例，對其從1997年首次取得美國FDA的IND以來，進行的一系列后續(xù)研究以及美國II期臨床研究的全過程進行系統(tǒng)總結(jié)和回顧，探討與美國FDA溝通的最新經(jīng)驗和體會，對中藥未來的國際研發(fā)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.