| 欧盟成员国植物药产品审评现状分析及启示 |
| |
| 引用本文： | 李浩,田侃,喻小勇,闵晓青. 欧盟成员国植物药产品审评现状分析及启示[J]. 中草药, 2016, 47(24): 4494-4498 |
| |
| 作者姓名： | 李浩 田侃 喻小勇 闵晓青 |
| |
| 作者单位： | 南京中医药大学卫生经济管理学院, 江苏 南京 210023;南京中医药大学卫生经济管理学院, 江苏 南京 210023;南京中医药大学卫生经济管理学院, 江苏 南京 210023;南京中医药大学卫生经济管理学院, 江苏 南京 210023 |
| |
| 基金项目： | 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。
|
| 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 |
| 收稿时间： | 2016-07-19 |
Analysis on current status of assessment on herbal medicinal products in EU and its enlightenment |
| |
| LI Hao,TIAN Kan,YU Xiao-yong and MIN Xiao-qing. Analysis on current status of assessment on herbal medicinal products in EU and its enlightenment[J]. Chinese Traditional and Herbal Drugs, 2016, 47(24): 4494-4498 |
| |
| Authors: | LI Hao TIAN Kan YU Xiao-yong MIN Xiao-qing |
| |
| Affiliation: | School of Health Economics and Management, Nanjing University of Chinese Medicine, Nanjing 210023, China;School of Health Economics and Management, Nanjing University of Chinese Medicine, Nanjing 210023, China;School of Health Economics and Management, Nanjing University of Chinese Medicine, Nanjing 210023, China;School of Health Economics and Management, Nanjing University of Chinese Medicine, Nanjing 210023, China |
| |
| Abstract: | 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. |
| |
| Keywords: | directive 2004/24/EC herbal drug Chinese patent drug EU monograph registration of herbal drug |
| 本文献已被 CNKI 等数据库收录！ |
| 点击此处可从《中草药》浏览原始摘要信息 |
|
点击此处可从《中草药》下载全文 |
|
