| 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):. |
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| 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） |
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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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