| 赵胜楠,赵士杰,屠佳峰,钱忠直,李铂.加拿大天然药品上市许可制度的研究与实践[J].中国药事,2021,35(1):215-220 |
| 加拿大天然药品上市许可制度的研究与实践 |
| Research and Practice of Canadian Natural Health Products Marketing Authorization System |
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| DOI：10.16153/j.1002-7777.2021.02.014 |
| 中文关键词: 天然药品 加拿大市场准入 药品国际注册 中药国际化 |
| 英文关键词: natural health products Canada marketing authorization international drug registration internationalization of Chinese Medicine |
| 基金项目:国家重点研发计划资助(编号 2017YFC1703700-02) |
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| 中文摘要: |
| 目的：研究加拿大天然药品上市制度并加以实践，旨在为我国中医药企业提供另一种国际化战略的市场选择。方法：以加拿大卫生部天然药品相关政策法规和注册指南文件为基础，探索天然药品注册技术路径和标准规范，通过比较分析加拿大天然药品的定义、注册申请类别、注册技术标准，寻求突破加拿大市场准入政策壁垒和技术壁垒的策略方法。结果与结论：加拿大天然药品上市许可途径分为简易申请、传统申请和非传统申请。不同注册申请类别对适应症声称内容、安全性/有效性支持性证据要求不同。在选择适当注册途径基础上，通过合理设计适应症表述，充分利用加拿大认可的权威文献等措施， 中药产品能够获得加拿大卫生部技术审评认可。以我国典型中药品种板蓝根颗粒进行传统申请注册实践，成功取得了加拿大天然药品上市许可证。 |
| 英文摘要: |
| Objective: To study Canadian Natural Health Products (NHPs) regulatory system and put it into practice, so as to provide our Traditional Chinese Medicine (TCM) enterprises with a choice of international strategy. Methods: Based on Health Canada NHPs policies, regulations and registration guidance documents, this paper explored the registration pathway and technical standards of NHPs. Through comparing and analyzing the definition, registration classification, and technical standard requirements of Canadian NHPs, this paper tries to seek strategic methods to break through the policy and technical barriers of Canadian market authorization. Results and Conclusion: Canadian NHPs registration pathways include compendial, traditional and nontraditional application. Different registration pathways have different requirements of indication claims, safety and effectiveness evidence. Based on choosing the appropriate registration pathway, reasonably indication design and sufficiently using authoritative literatures recognized by Health Canada, TCM products can be approved by the Canadian Health Department in technical review. As a traditional application for registration practice, Isatis RootGranules, a typical TCM product has successfully obtained the Canadian NHP Product License. |
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