世界中医药
文章摘要
引用本文:张钰,沙康,吴正红,祁小乐.中成药欧盟注册分析[J].世界中医药,2020,(17):.  
中成药欧盟注册分析
Analysis of European Union Registration of Chinese Patent Medicine
投稿时间:2019-05-29  
DOI:10.3969/j.issn.1673-7202.2020.17.030
中文关键词:  中成药  欧盟  出口  质量标准  植物药专论  注册  政策法规  技术性贸易壁垒
English Keywords:Chinese patent medicine  EU  Export  Quality standard  Botanical monograph  Registration  Policies and regulations  Technical trade barriers
基金项目:中国药科大学双一流国际药品注册创新团队(CPU2018GY40)
作者单位
张钰,沙康,吴正红,祁小乐 中国药科大学药学院南京211198 
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中文摘要:
      自2004年起,欧盟和美国分别发布了《传统植物药注册程序指令》和《植物药产品指南》,掀起了中药的新篇章,西方发达国家第一次在法律层面上认可中药作为药品的地位,现通过对欧盟植物药注册法规法律的探讨以及注册成功案例的分析,为我国中成药国际化注册提供一定参考。
English Summary:
      Since 2004,the European Union and the United States have separately issued the Directive on Registration Procedures of Traditional Botanical and Guidance for Botanical Drug Products,setting off a new chapter in Chinese medicine.For the first time in the Western developed countries,the status of Chinese medicine as a drug is recognized at the legal level.This paper provides a reference for the international registration of Chinese patent medicine through the discussion of EU botanical registration laws and regulations and the analysis of successful registration cases.
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