| 朱卓辉,李雨,江海兰,姚东明.基于多源流理论的中药分类注册政策研究[J].中国药事,2023,(8):881-889 |
| 基于多源流理论的中药分类注册政策研究 |
| Research on the Classification and Registration Policy of Traditional Chinese Medicine Based on the Multi-source Theory |
| 投稿时间：2023-02-06 |
| DOI：10.16153/j.1002-7777.2023.08.004 |
| 中文关键词: 中药 注册分类 审评审批 多源流理论 政策演变 |
| 英文关键词: traditional Chinese medicine registration classification evaluation and approval multi-source theory policy evolution |
| 基金项目:2021年江西中医药大学经济与管理学院科研训练计划：基于多源流理论的中药分类注册政策研究 |
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| 中文摘要: |
| 目的：通过分析中药注册分类政策的历史变革过程，为新形势下中药注册分类管理制度和审评审批技术评价体系的继续改革和完善提供思路。方法：运用多源流理论模型，从问题源流、政策源流、政治源流3个方面分析我国中药注册分类管理制度的政策演变过程，说明中药注册分类制度改革和建立并完善遵循中药发展规律的审评审批技术评价体系的重要性及必要性。结果与结论：注册分类作为中药注册管理制度的核心内容，直接关系到中药未来的研发注册和创新趋势。结合中药注册审批的实际情况， 针对上市中药审评核查资源有限等现实挑战，建议国家相关部门、政策企业家等多方主体加强配合，进一步推进中药注册分类制度的改革和完善，促进中药研发和创新。 |
| 英文摘要: |
| Objective: This article analyzes the historical transformation process of traditional Chinese medicine registration classification policies, and provides thinking for the continuous reform and improvement of the management system for traditional Chinese medicine registration classification and the evaluation system for review and approval technology under the new situation. Methods: The multi-source theoretical model was used, the policy evolution process of my country's traditional Chinese medicine registration classifi cation management system was analyzed from three aspects: problem origin, policy origin, and political origin. The importance and necessity of the reform of TCM registration classification system and the establishment and improvement of the review and approval technical evaluation system in accordance with the law of TCM development was explained. Results and Conclusion: As the core content of the registration management system of traditional Chinese medicine, registration classifi cation is directly related to the future R&D registration and innovation trend of traditional Chinese medicine. Combined with the actual situation of registration and approval of traditional Chinese medicine, and in the face of practical challenges such as limited resources for evaluation and verifi cation of listed traditional Chinese medicine, relevant national departments, policy entrepreneurs and other entities could strengthen cooperation, further promote the reform and improvement of the classifi cation system for traditional Chinese medicine registration, and promote the research and innovation of traditional Chinese medicine. |
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