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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 changes in the global disease spectrum and human health needs, how to ensure the sustainability of a steady stream of innovative drug research and development and going public is a thorny issue commonly faced by the pharmaceutical industry both at home and abroad. In recent years, the United States, Europe and Canada and other western countries have gradually adjusted the laws and regulations on the control of botanical drugs. While recognizing the equal status of botanical drugs and non-botanical drugs, it also relaxed the technology of product approval and listing on a certain extent Claim. This paper briefly analyzes the changes of the regulations on herbal medicine in Europe and the United States. Taking the application of compound Danshen Dripping Pills, the first model internationalization of Chinese medicine, as an example, a series of follow-up Research and the whole process of Phase II clinical research in the United States to systematically summarize and review the latest experience and understanding of communication with the US FDA and put forward a new prospect for the future international R & D of Chinese medicine.