| 浅议中成药源头注册管理 |
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| 引用本文： | 陆文亮,李鸿彬,张琴,董海鸥,丁文侠.浅议中成药源头注册管理[J].中国药事,2010,24(11):1047-1049. |
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| 作者姓名： | 陆文亮 李鸿彬 张琴 董海鸥 丁文侠 |
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| 作者单位： | 1. 天士力集团研究院,天津,300402
2. 天津中医药大学附属医院 |
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| 摘 要： | 目的建议中成药实施源头注册管理。方法分析目前中成药源头管理现状以及源头管理的必要性,以及如何对中成药新药和仿制药实行源头注册管理。结果与结论建立中成药源头管理,从源头上保证中成药质量均一性和稳定性;促使中成药进一步与国际接轨,推进中成药标准化和国际化进程。
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| 关 键 词： | 中成药 源头管理 注册 |
Simple Discussion of Source Registration Management of TCM |
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| Lu Wenliang,Li Hongbin,Zhang Qin,Dong Haiou,Ding Wenxia.Simple Discussion of Source Registration Management of TCM[J].Chinese Pharmaceutical Affairs,2010,24(11):1047-1049. |
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| Authors: | Lu Wenliang Li Hongbin Zhang Qin Dong Haiou Ding Wenxia |
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| Institution: | Lu Wenliang,Li Hongbin,Zhang Qin1,Dong Haiou and Ding Wenxia(Institute of Tasly Group,Tianjin 300402,1Subsidiary Hospital of Tianjin University of TCM) |
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| Abstract: | Objective Suggesting the implement of source registration management of TCM.Methods Analyzing the current status and necessary of source Registration management,to suggest how to manage sources of new drugs and generic drugs of TCM.Results and Conclusion The source registration management should be established in order to ensure quality and stability of TCM.The international integration of TCM should be further promoted.Standardization and internationalization of TCM should be advanced. |
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| Keywords: | TCM source management registration |
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