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。 Modernization of Chinese medicine research, internationalization is the main trend of the development of Chinese medicine. In Australia, new drugs are mostly multi-pronged alternative medicine, mainly in the form of listed drugs to apply for registration. Australia Register (List) The drug application information covers a broad description of the drug ingredients, pharmacological and toxicological studies, treatment statements, pharmaceutical dosage forms and side effects. For each part of the detailed specifications and instructions to ensure that the applicant accurately understand the registration (listing) of the drug application requirements, which also on the domestic new drug research and development have a very important reference.