| 欧洲联盟草药专论和草药目录审核和修订程序介绍 |
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| 引用本文： | 萧惠来. 欧洲联盟草药专论和草药目录审核和修订程序介绍[J]. 现代药物与临床, 2018, 41(4): 534-539 |
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| 作者姓名： | 萧惠来 |
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| 作者单位： | 国家食品药品监督管理总局 药品审评中心, 北京 100038 |
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| 摘 要： | 欧洲药品局（EMA）于2017年10月发布了"欧洲联盟草药专论和草药目录审核和修订程序"。该文件详细描述了欧洲联盟草药专论和草药目录的修订过程,包括审核新数据、判断新数据与需要修订专论的相关性和修订。详细介绍该文件的主要内容,期望对我国中草药的医学评价有所启迪。
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| 关 键 词： | 欧洲药品局 欧洲联盟草药专论 草药目录 修订 程序 |
| 收稿时间： | 2017-12-04 |
Introduction of procedure for review and revision of European Union herbal monographs and European Union list entries |
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| XIAO Huilai. Introduction of procedure for review and revision of European Union herbal monographs and European Union list entries[J]. Drugs & Clinic, 2018, 41(4): 534-539 |
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| Authors: | XIAO Huilai |
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| Affiliation: | Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China |
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| Abstract: | The EMA issued the "Procedure for the review and revision of European Union herbal monographs and European Union list entries" in October 2017. The document detailed the revision process of European Union herbal monographs and European Union list entries, including reviewing new data, judging the relevance of new data and the need of revision of monograph and revising. This paper introduced the contents of this document in detail, which is expected to enlighten the medical evaluation of Chinese herbal medicines. |
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| Keywords: | EMA European Union herbal monographs list entries revision procedure |
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