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本文以美国FDA植物药开发指南(2015修订稿草案)内容为研究对象;重点分析指南针对临床研究(尤其是后期临床研究)部分的建议和要求,尝试剖析植物药指南的立法思路,分析探讨后期临床研究的重点和难点问题,结合国内企业现实情况提出了系列的可能对策。同时结合FDA上市两个植物药产品案例,分析植物药研发指南法规和成功经验对我国中药新药研发的指导意义和启示,以促进我国中药创新研究进程。
This article takes the content of the FDA Guideline for the Development of Botanical Medicines (revised version of 2015) as the research object. It mainly analyzes the suggestions and requirements of the guideline for the clinical research (especially the later clinical research), attempts to analyze the legislative ideas of the guideline of botanical drugs, Clinical research focus and difficult issues, combined with the actual situation of domestic enterprises put forward a series of possible countermeasures. At the same time, combined with FDA listed two cases of botanical drug products, the guideline and inspiration of analyzing the research and development regulations and successful experiences of botanical drug on the research and development of Chinese traditional medicine in our country are analyzed to promote the research progress of traditional Chinese medicine in our country.