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）对草药品种进入恢盟草药产品专论典有重要指导意义。本文对这份程序文件进行了详细解读并提出了可行性建议。建议我国中药品种可以先申请进入欧盟草药产品专论，在成功进入后，再根据欧盟2004／24／EC指令申请简化注册。这是促进中药品种进入欧盟市场的有效途径之一。
Directive 2004/24/EC of the European Parliament and the Council entered into force on April 30th, 2004. Aider 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.
出处
《国际中医中药杂志》
2011年第5期412-416,共5页
International Journal of Traditional Chinese Medicine
基金
中国中医科学院自主选题（项目编号：ZZ20090502）志谢 叶祖光研究员对本文的审阅
