澳大利亚获批中成药品种研究及思考  

Research and thinking of Chinese medicine prescriptions approved in Australia

作　　者：孙昱 SUN Yu(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,北京100022

出　　处：《中国临床药理学杂志》2020年第16期2595-2600,共6页The Chinese Journal of Clinical Pharmacology

摘　　要：澳大利亚获批中成药有一部分来源于我国古代名方,作为登记类药品获批上市。澳大利亚政府卫生部治疗用品管理部门(TGA)对于相同古代名方来源的不同获批产品,在处方药味、处方药味用量比例、制备方法、剂型和适应证等方面存在的差异有较好的接受度。该思路可为我国古代经典名方的不同获批产品之间的质量一致性控制提供参考。本文重点对澳大利亚中成药获批品种的适应证及其获批依据进行了分析,期望为无特定适应证的证候类中药或民族药提供新的申报思路。Some of the Chinese medicine prescriptions approved in Australia originated from ancient famous recipes and were approved as listed medicines. TGA has a good acceptance of the differences in pharmaceutical ingredients, dosage ratios of pharmaceutical ingredients, preparation methods, dosage forms, and indications for different approved products from the same ancient famous recipe. This idea can provide reference for quality consistency control between different approved products of ancient classic prescriptions in China. This article focuses on the indications of approved Chinese medicine prescriptions and their approval basis, and hopes to provide innovative registration approval ideas for syndrome traditional Chinese medicine or ethnopharmaceuticals with no specific indications.

关 键 词：澳大利亚政府卫生部治疗用品管理部门 澳大利亚治疗用品注册簿 日本汉方药 古代经典名方 证候类中药 民族药 

分 类 号：R28[医药卫生—中药学]