CAJ | 학술논문

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进行了详细解读并提出了可行性建议.建议我国巾药品种町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指令中请简化注册.这是促进中药品种进入欧盟市场的有效途径之一.
구맹2004/24/EC지령,우2004년4월30일생효,7년과도기우2011년4월결속,이아국상무일개중약품충재구맹작위전통초약산품성공주책.구맹약품심평관리국반포적"전통초약산품진입구맹초약산품전론정서"(EMEA/HMPC/182320/2005)대초약품충진입구맹초약산품전론구유중요지도의의.본문대저빈정서문건진행료상세해독병제출료가행성건의.건의아국건약품충정이선신청진입구맹초약산품전론,재성공진입후,재근거구맹2004/24/EC지령중청간화주책.저시촉진중약품충진입구맹시장적유효도경지일.
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.