澳大利亚登记(列册)药物申请和评估流程及对中药新药研究的启示  

Enlightenment of drug application and evaluation procedures of medicines registered(listed) in Australia on studies of new traditional Chinese medicines

作　　者：任建勋[1] 刘建勋[1] 

机构地区：[1]中国中医科学院西苑医院基础医学研究所,中药药理北京市重点实验室,北京100091

出　　处：《中国中药杂志》2014年第21期4265-4267,共3页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2012ZX09101214);北京市科技计划"十病十药"研发项目(Z121102001112006)

摘　　要：中药新药研究现代化、国际化是当前中医药发展的主要趋势。在澳大利亚中药新药多指替代药物,主要以列册药品的形式申请注册上市。澳大利亚登记(列册)药物申请资料主要涵盖药物成分的详细说明、药理学和毒理学研究、治疗声明、药品剂型和副作用。针对每部分都有详尽的规范和说明,保证申请人准确理解登记(列册)药品的申请要求,这同时也对国内中药新药的研究和发展有非常重要的借鉴作用。Modern and international studies on new traditional Chinese medicines are the main trend of the development of traditional Chinese medicines at present. In Australia, new traditional Chinese medicines refer to complementary medicines, which are mainly registered and launched as listed medicines. The application documents of registered （listed） medicines in Australia mainly cover detailed description of active pharmaceutical ingredients, pharmacological and toxicological studies, dosage form and adverse effects. Each part has detailed specifications and instructions, which helps ensure that applicants could accurately understand the requirements in application for registering （listing） medicines, and provides very important reference to the studies and development of new traditional Chinese medicines in China.

关 键 词：澳大利亚 登记药物 流程 中药新药 

分 类 号：R28[医药卫生—中药学]