对美国FDA最新版《工业界植物药研发指南》的评述

发布时间：2018-08-20 15:59

【摘要】：2016年12月美国FDA发布了《工业界植物药研发指南》最新定稿版,通过对美国FDA植物药指南新旧版本的对比发现,尽管FDA认同植物药传统应用经验的历史事实,并在早期临床研究中给予了"宽进"政策,但随着研发的深入,强调了全程质量控制、临床受试样品和原料与上市产品及其原料在质量和疗效上的一致性,保障终产品的"严出"。指南推荐了一批新的方法和思路,如从药材到成品质量控制的"证据链完整性法"、生物测定法、质量平衡法、多批次临床研究设计、剂量-响应效应等技术要求,以确保临床研究用原料、受试样品与拟上市用原料、成品的质量一致性,进而保障疗效的一致性;在监管上同时要求药材的GACP和中间体与成品的cGMP。
[Abstract]:In December 2016, the United States FDA released the latest final version of the guidelines for Industrial plant-based Medicines Research and Development. By comparing the new and the old versions of the FDA guidelines for Plant Medicines in the United States, it was found that despite the historical fact that FDA shares the historical experience of traditional application of plant medicines, In the early clinical research, the policy of "wide advance" was given, but with the development of research and development, the quality control of the whole process and the consistency of the quality and efficacy of the clinical samples and raw materials with the products and their raw materials were emphasized. To ensure the "strict" of the final product. The guidelines recommend a number of new methods and ideas, such as "evidence chain integrity" for quality control from medicinal materials to finished products, biometric methods, mass balance methods, multiple batches of clinical research designs, dose-response effects, and other technical requirements. In order to ensure the consistency of the quality of the raw materials for clinical research and the raw materials to be put on the market, and then to ensure the consistency of curative effect, the supervision also requires the GACP of medicinal materials and the cGMPs of intermediates and finished products.
【作者单位】：中国中医科学院中药研究所中药质量控制技术国家工程实验室国家中医药管理局中药过程控制技术重点研究室;中国中医科学院;国家食品药品监督管理总局;
【基金】：国家食品药品监督管理总局软课题“中药新药研发模式及其注册管理思路研究” 国家中医药行业科研专项(201507002-3)
【分类号】：R95

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