欧盟传统草药产品简易注册分析

Analysis of simplified registration of traditional herbal medicinal products in European Union

欧洲在世界中草药市场占据重要地位,中药在欧盟的注册对中药国际化发展意义重大。欧盟药品管理局对草药产品的注册监管具有较为完备的管理体系与法规指南,《欧盟传统草药产品注册指令》(2004/24/EC)的颁布标志着我国传统中成药可通过简易注册进入欧盟市场。本文从欧盟传统草药产品(Traditional Herbal Medicinal Products,THMPs)的注册条件、注册管理机构及文件指南出发,对欧盟THMPs简易注册的申请条件从药用历史、质量要求及申请资料格式等方面进行分析,为我国传统中成药在欧盟的简易注册提供参考建议。

Europe occupies an important position in the world herbal medicine market.The registration of Traditional Chinese Medicine(TCM)in EU is of great significance to the internationalization of TCM.The European Medicines Agency(EMA)has designed a relatively complete management system and regulatory guidelines for the registration and supervision of herbal medicinal products.The promulgation of the DIRECTIVE 2004/24/EC(2004/24/EC)indicates that TCM could enter the EU market through simplified registration.Based on the registration conditions,registration authority and document guideines of Traditional Herbal Medicinal Products(THMPs)in EU,this paper analyzes the application requirements of simple registration of traditional herbal products in EU,and provides suggestions for the simplified registration of TCM in EU according to the registration requirements of medicinal history,quality requirements and application data format.