欧盟成员国植物药产品审评现状分析及启示  

Analysis on current status of assessment on herbal medicinal products in EU and its enlightenment

作　　者：李浩[1] 田侃[1] 喻小勇[1] 闵晓青 

机构地区：[1]南京中医药大学卫生经济管理学院,江苏南京210023

出　　处：《中草药》2016年第24期4494-4498,共5页Chinese Traditional and Herbal Drugs

基　　金：国家中医药管理局基金资助项目(SATCM-2014-FZ01);教育部哲学社会科学研究重大课题攻关项目(14JZD025)

摘　　要：欧盟的植物药发展处于世界领先水平,开拓中成药的欧盟市场对中药国际化具有重要意义,然而当前我国中成药在欧盟的注册面临诸多挑战。首先介绍中成药在欧盟获得药品身份的上市路径,然后对欧盟成员国植物药产品审评总体状况、获批药品的组分特点、植物药专论的应用以及主要适应症等方面进行分析,最终提出我国中成药产品在欧盟通过注册的相关建议。It is of great importance to bring proprietary Chinese medicines to EU as its herbal medicinal product is world-leading, yet the current status for registrations from China is full of challenges. The routes for registration of herbal medicinal products are introduced at first and then the current registration status on the overall assessment of the products, the characteristics of combinations, the utilization of EU monograph and main indications are analyzed. Suggestions on registering proprietary Chinese medicines are made in the end.

关 键 词：2004/24/EC指令 植物药 中成药 欧盟植物药专论 植物药注册 

分 类 号：R288[医药卫生—中药学]