对EMA草药质量标准指南（第3修订版草案）的思考  

Thoughts on EMA herbal quality standards guide(draft revision 3)

作　　者：孙昱 萧惠来[1] SUN Yu;XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《药物评价研究》2019年第10期1920-1934,共15页Drug Evaluation Research

摘　　要：草药及其产品的质量标准具有区别于化学药品或生物制品的特殊性,因此欧洲药品管理局(EMA)于2018年发布了"质量标准指南:草药物质、草药制剂和草药产品或传统草药产品的检验程序和可接受标准(第3修订版草案)"。EMA的草药及其产品的情况与我国中药有相似之处,从起始物料到成品多为活性成分未知的复杂混合物。目前我国尚未制定关于中药或中药材(饮片)质量标准相关指导原则。介绍该指南文件的主要内容,并结合中药质量监管情况进行分析,以期EMA相关质量标准制定的指导思路为制定中药质量标准提供参考。The quality standards for herbs and their products differ from the specifications of the chemical drugs or biological products, so the European Medicines Agency(EMA) issued a " Guideline on specifications: test procedures and acceptance criteria for herbal substances, and herbal preparations for herbal and medicinal products/traditional herbal medicinal products(draft revision3) " in 2018, The situation of EMA’s herbs and their products is similar to that of traditional Chinese medicine. From the starting materials to the finished products, complex mixtures of active ingredients are unknown. At present, China has not yet formulated relevant guidelines for the quality standards of traditional Chinese medicine or Chinese herbal medicines(decoction pieces).Introduce the main contents of the guidance document and analyze the quality supervision of traditional Chinese medicine, with a view to guiding the development of EMA related to quality standards.

关 键 词：欧洲药品管理局 草药产品 草药制剂 草药物质 检验程序 可接受标准 

分 类 号：R288.1[医药卫生—中药学] R951[医药卫生—中医学]