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(guó)內(nèi)外醫(yī)藥界普遍面臨的棘手問(wèn)題。近年來(lái)，美、歐和加拿大等西方國(guó)家陸續(xù)對(duì)植物藥的管理法規(guī)進(jìn)行了靈活調(diào)整，在認(rèn)可植物藥與非植物藥具有等同地位的同時(shí)，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(jiǎn)要分析歐美國(guó)家中藥植物藥監(jiān)管法規(guī)的變化，以我國(guó)中藥國(guó)際化的第一個(gè)示范品種復(fù)方丹參滴丸的申請(qǐng)為例，對(duì)其從1997年首次取得美國(guó)FDA的IND以來(lái)，進(jìn)行的一系列后續(xù)研究以及美國(guó)II期臨床研究的全過(guò)程進(jìn)行系統(tǒng)總結(jié)和回顧，探討與美國(guó)FDA溝通的最新經(jīng)驗(yàn)和體會(huì)，對(duì)中藥未來(lái)的國(guó)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.