摘要
欧盟在全球植物药市场的地位举足轻重,开展欧盟注册对中药国际化具有重要意义。回溯国内对中药欧盟注册法规的研究已有10余年,仍存部分认识偏差和研究不足。该文旨在系统分析国内欧盟草药药品法规的研究现状,并针对其中研究认识不足的主要方面,即,欧盟传统草药药品集中与分权的监管体系、传统草药的上市审批类别、欧盟草药专论和草药目录等,对2004/24/EC法令的疑难问题进行进一步解析,以期为中药欧盟注册提供参考。
Registration of Chinese patent medicine in European Union (EU) is of great significance to the internationalization of traditional Chinese medicine as EU market acts as an important position in the global botanical market. In retrospect, the domestic studies on EU regulations of traditional herbal medicinal products have been conducted for more than 10 years, but there is still some cognitive bias and lack of research. In this paper, a review of the relevant research progress and the main misunderstanding problems about Directive 2004/24/EC, like the centralized and decentralized supervision system of traditional herbal medicinal products in the EU, marketing authorization procedures for traditional herbal medicinal products, Community Herbal Monograph and List Entries, would be systematically analyzed, so as to provide reference for the registration of Chinese patent medicine in EU.
作者
瞿礼萍
张晓群
熊晏
王一涛
邹文俊
QU Li-ping ZHANG Xiao-qun XIONG Yan WANG Yi-tao ZOU Wen-junl(College of Pharmacy, Chengda University of Traditional Chinese Medicine, Chengdu 610041, China Institute of Chinese Medical Sciences, University of Maeau, Maeau 999078, China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2017年第20期4040-4044,共5页
China Journal of Chinese Materia Medica
基金
国家"重大新药创制"科技重大专项(2012ZX09101231)
关键词
2004/24/EC法令
上市审批程序
草药专论和目录
中药欧盟注册
Directive 2004/24/EC
marketing authorization procedures
Community Herbal Monograph and List Entries
EU reg-istration for traditional Chinese medicine