| 中药审评审批改革与中药注册分类——2020第四届中国创新药论坛发言 |
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| 引用本文： | 王海南.中药审评审批改革与中药注册分类——2020第四届中国创新药论坛发言[J].中国新药杂志,2021(3):193-196. |
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| 作者姓名： | 王海南 |
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| 作者单位： | 国家药品监督管理局注册管理司 |
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| 摘 要： | 本文讲述了2020年中药审评审批制度改革的缘由,详细阐述了中药注册分类改革的内容,论述了本次改革的几个创新的理念,包括中药新药研发中的三结合审评证据体系、中药新药研发中的质量控制和临床定位,并且介绍了这次中药审评审批制度改革的实施进度安排,为中药新药研发提供了重要指导。
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| 关 键 词： | 中药 审评 新药研发 注册 改革 制度 |
Reform of evaluation and approval system of traditional Chinese medicine and the registration classification |
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| WANG Hai-nan.Reform of evaluation and approval system of traditional Chinese medicine and the registration classification[J].Chinese Journal of New Drugs,2021(3):193-196. |
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| Authors: | WANG Hai-nan |
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| Institution: | (Department of Drug Registration,National Medical Product Administration,Beijing 100038,China) |
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| Abstract: | This paper describes the reasons for the reform of the evaluation and approval system of traditional Chinese medicine (TCM) in 2020,elaborates the contents of its reform of the registration classification in detail.Several innovative ideas of the reform were discussed,including the three-combined evidence system,the quality control and clinical positioning in new TCM research and development. This paper also announces the schedule of the reform implementation regarding evaluation and approval system of TCM,providing important guidance for the research and development of new TCM. |
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| Keywords: | traditional Chinese medicine evaluation new drug research and development registration reform system |
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