| 欧盟传统草药药品法规疑难问题解析 |
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| 引用本文： | 瞿礼萍,张晓群,熊晏,王一涛,邹文俊.欧盟传统草药药品法规疑难问题解析[J].中国中药杂志,2017,42(20):4040-4044. |
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| 作者姓名： | 瞿礼萍 张晓群 熊晏 王一涛 邹文俊 |
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| 作者单位： | 成都中医药大学 药学院, 四川 成都 610041,成都中医药大学 药学院, 四川 成都 610041,成都中医药大学 药学院, 四川 成都 610041,澳门大学 中华医药研究院, 澳门 999078,成都中医药大学 药学院, 四川 成都 610041 |
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| 基金项目： | 国家"重大新药创制"科技重大专项（2012ZX09101231） |
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| 摘 要： | 欧盟在全球植物药市场的地位举足轻重,开展欧盟注册对中药国际化具有重要意义。回溯国内对中药欧盟注册法规的研究已有10余年,仍存部分认识偏差和研究不足。该文旨在系统分析国内欧盟草药药品法规的研究现状,并针对其中研究认识不足的主要方面,即,欧盟传统草药药品集中与分权的监管体系、传统草药的上市审批类别、欧盟草药专论和草药目录等,对2004/24/EC法令的疑难问题进行进一步解析,以期为中药欧盟注册提供参考。
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| 关 键 词： | 2004/24/EC法令 上市审批程序 草药专论和目录 中药欧盟注册 |
| 收稿时间： | 2017/8/4 0:00:00 |
Analysis of difficult problems on European Union laws and regulations of traditional herbal medicinal products |
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| QU Li-ping,ZHANG Xiao-qun,XIONG Yan,WANG Yi-tao and ZOU Wen-jun.Analysis of difficult problems on European Union laws and regulations of traditional herbal medicinal products[J].China Journal of Chinese Materia Medica,2017,42(20):4040-4044. |
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| Authors: | QU Li-ping ZHANG Xiao-qun XIONG Yan WANG Yi-tao and ZOU Wen-jun |
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| Institution: | College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 610041, China,College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 610041, China,College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 610041, China,Institute of Chinese Medical Sciences, University of Macau, Macau 999078, China and College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 610041, China |
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| Abstract: | Registration of Chinese patent medicine in European Union (EU) is of great significance to the internationalization of traditional Chinese medicine as EU market acts as an important position in the global botanical market. In retrospect, the domestic studies on EU regulations of traditional herbal medicinal products have been conducted for more than 10 years, but there is still some cognitive bias and lack of research. In this paper, a review of the relevant research progress and the main misunderstanding problems about Directive 2004/24/EC, like the centralized and decentralized supervision system of traditional herbal medicinal products in the EU, marketing authorization procedures for traditional herbal medicinal products, Community Herbal Monograph and List Entries, would be systematically analyzed, so as to provide reference for the registration of Chinese patent medicine in EU. |
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| Keywords: | Directive 2004/24/EC marketing authorization procedures Community Herbal Monograph and List Entries EU registration for traditional Chinese medicine |
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