澳大利亚中药监管与审批现状及我国中药产品注册分析 |
投稿时间:2020-04-20 点此下载全文
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引用本文:宋永军,刘建勋,李浩.澳大利亚中药监管与审批现状及我国中药产品注册分析[J].中国现代中药,2021,23(5):760-765 |
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基金项目:国家自然科学基金项目(81873041) |
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中文摘要:中药在澳大利亚归属于补充药物范畴。《澳大利亚补充药品监管指南8.0》和《评册药物证据指南1.1》出台后,澳大利亚形成了完整的以风险管理为核心原则的风险评估机制,根据补充药品应用的风险程度划分为低风险、中等风险和高风险3类。根据审批途径和申请类别,按照国际协调人用药品技术要求理事会(ICH)的通用技术文件(CTD)的5个模块提交申请资料,包括药品质量报告、安全性的非临床研究报告、疗效的临床研究报告、处方信息等,并以列册药物(AUSTL)、评册药物[AUSTL(A)]和注册补充药物(AUSTR)3种途径申请审批上市。只有被列入澳大利亚治疗用品登记注册目录(ARTG)的治疗性产品才能在澳大利亚进行合法的上市销售。通过对澳大利亚补充药物监管现状的分析可以看到澳大利亚新药注册制度经过多年的发展已经比较完善,对中药产品的注册管理值得我们深入了解和借鉴。这对于开拓我国中药企业海外市场、提高中药的技术研发能力、扩大中医药的影响力都有参考意义。 |
中文关键词:中草药 澳大利亚 补充药物 药品注册 |
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Australian Herbal Medicines Regulatory Approval Procedures and Registration Analysis of Traditional Chinese Medicine |
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Abstract:In Australia the demand of Chinese medicine has increased drastically over the past decades,medicinal products containing such ingredients as certain herbs,vitamins and minerals,nutritional supplements,including traditional Chinese medicines products are referred to as ″complementary medicines″ and are regulated as medicines by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989 (the Act) and the supporting Therapeutic Goods Regulations 1990 (the Regulations). Unless exempt any therapeutic product for which indications are made must be entered on the Australian Register of Therapeutic Goods (ARTG) before it can be legally imported,exported,manufactured or supplied for use in Australia. Within the regulatory framework,complementary medicines are either Registered (AUSTR) or Listed (AUSTL) or Assessed listed[AUST(A)] on the ARTG categorized on their ingredients contain and therapeutic indications made for the medicine. Through the analysis of the regulatory of complementary medicines in Australia,it should be recognized that its registration system has been relatively mature after years of development. The registration of traditional Chinese medicine is worthy of our in-depth understanding and reference. It is of far-reaching significance for expanding the overseas markets of corporations,improving the research,developing capabilities,and expanding the influence. |
keywords:traditional Chinese medicine Australia complementary medicines registered complementary medicines |
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