欧盟是全球最重要的区域一体化组织，也是西方最成熟的植物药市场，2004年《欧盟传统草药指令》（2004/24/EC）的颁布标志着欧盟草药药品注册管理制度的成熟和完善，不仅对统一监管草药具有里程碑式意义，而且为中药国际化发展提供了重要机遇。2004/24/EC法令颁布至今已有17年，已批准2000余件草药药品上市申请，而我国仅有极少数中药产品成功在欧盟成员国获批，中药欧盟注册仍然任重道远。旨在系统分析欧盟草药药品注册管理制度及其实施有关数据情况，并探索未来中药欧盟注册的思路与策略，以期为有关企业及政府部门提供参考。

European Union (EU) is the most important regional integration organization in the whole world as well as the largest market of herbal medicinal products in the west European Union Directive on Traditional Herbal Medicines (2004/24/EC) in 2004 marked the formation of an excellent regulatory system of herbal medicinal products in EU, which not only acted as a landmark for the unified regulation of herbal medicinal products, but also provide important opportunities to EU registration of traditional Chinese medicine. Up to now, it has been 17 years since 2004, and more than 2000 applications for the registration of herbal medicinal products have been approved. However, only few traditional Chinese medicines have been successfully registered. Thus, there are still some challenges and bottlenecks for successful registration of traditional Chinese medicine in EU. European regulation of herbal medicinal products and the relevant implementation data were systematically review in this paper, in order to explore the future ideas and strategies for EU registration of traditional Chinese medicine and may provide references to relevant stakeholders such as enterprises and governmental organizations.

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国家社会科学基金青年项目（18CGJ036）