中药植物药国际研发新展望.pdfVIP

Drug Evaluation Research 第 34 卷 第 1 期 2011 年 2 月 - 1 - • 专 论 • 中药植物药国际研发的新展望 赵利斌，何 毅，郭治昕，孙 鹤 天津天士力集团公司研究院，天津 300410 摘 要：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。 关键词：疾病谱；中药；植物药；复方丹参滴丸；FDA ；临床研究；产学研联盟 中图分类号：R95 文献标志码：A 文章编号：1674 - 6376 (2011) 01 - 0001 - 07 New prospect on research and development of Chinese Materia Medica and phytomedicines in global ZHAO Li-bin, HE Yi, GUO Zhi-xin, SUN He Research Institute of Tasly Group, Tianjin 300410, China Abstract: 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 RD 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 RD of Dantonic (Fufang Danshen Dripping Pill, the 1st 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 RD of chinese materia medica put forward. Key words: disease spectrum; Chinese materia medica (CMM); phytomedicine; Dantonic (Fufang Danshe