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| 关于中药品种进入欧盟草药产品专论的几点建议 | |
| 引用本文： | 金莉,张卫,李军德,张瑞贤,邵爱娟,王谦,付京华,袁亚男,程明.关于中药品种进入欧盟草药产品专论的几点建议[J].国际中医中药杂志,2011,33(5):412-416. |
| 作者姓名： | 金莉 张卫 李军德 张瑞贤 邵爱娟 王谦 付京华 袁亚男 程明 |
| 作者单位： | 1. 中国中医科学院中药研究所办公室,北京,100700 2. 中国中医科学院本草文献研究室,北京,100700 3. 中国中医科学院中药鉴定与分子生药学研究室,北京,100700 4. 中国中医科学院中药新药研发中心 |
| 基金项目： | 中国中医科学院自主选题 |
| 摘 要： | 欧盟2004/24/EC指令,于2004年4月30日生效,7年过渡期于2011年4月结束,而我国尚无一个中药品种在欧盟作为传统草药产品成功注册.欧盟药品审评管理局颁布的"传统草药产品进入欧盟草药产品专论程序"(EMEA/HMPC/182320/2005)对草药品种进入欧盟草药产品专论具有重要指导意义.本文对这份程序文件... |
| 关 键 词： | 中药品种 欧盟草药产品专论 欧盟传统草药产品注册指令 传统草药产品 |
The suggestions on the entry of Chinese medicines into European Community monographs for traditional herbal medicinal products |
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| JIN Li,ZHANG Wei,LI Jun-de,ZHANG Rui-xian,SHAO Ai-juan,WANG Qian,FU Jing-hua,YUAN Ya-nan,CHENG Ming.The suggestions on the entry of Chinese medicines into European Community monographs for traditional herbal medicinal products[J].International Journal of Traditional Chinese Medicine,2011,33(5):412-416. | |
| Authors: | JIN Li ZHANG Wei LI Jun-de ZHANG Rui-xian SHAO Ai-juan WANG Qian FU Jing-hua YUAN Ya-nan CHENG Ming |
| Abstract: | Directive 2004/24/EC of the European Parliament and the Council entered into force on April 30th, 2004. After 7 years, there is no Chinese medicine to be registered successfully in European market as traditional herbal medicinal products. The thesis gives some ideas to tackle this problem. Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products (EMEA/HMPC/182320/2005) published by European Medicines Agency is an important guidance for traditional herbal products to enter European Community monographs. The thesis introduces and details the procedure as well as gives feasible suggestions about the procedure. It suggests that Chinese medicines enter European Community monographs first, and then apply the registration according to the directive 2004/24/EC. This is an easier access to European market. |
| Keywords: | Chinese medicines European Community monographs Directive 2004/24/EC Traditional herbal medicinal products |
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