| 引用本文:于金倩1，黄璐琦2，段文娟1，王志伟1，闫慧娇1，王晓1.世界卫生组织6大区域对草药生产和安全评估的监管概况[J].世界中医药,2023,(12):. |
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| 世界卫生组织6大区域对草药生产和安全评估的监管概况 |
| Regulatory Overview of the Production and Safety Evaluation for Herbal Medicines in the WHO's Six Regions |
| 投稿时间：2021-11-16 |
| DOI：10.3969/j.issn.1673-7202.2023.12.019 |
| 中文关键词: 世界卫生组织 草药 世界卫生组织6大区域 草药生产 生产质量管理规范 安全性评价 草药销售类型 监管概况 |
| English Keywords:World Health Organization Herbal medicine WHO's six regions Herbal medicine production Good Manufacturing Practice Safety evaluation Sale-types of herbal medicines Regulatory overview |
| 基金项目:中央本级重大增减支项目（2060302） |
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| 中文摘要: |
| 目前草药的全球化发展势头强劲，受到越来越多的关注。本研究主要针对草药的生产、安全性评价和销售类型对世界卫生组织（WHO）6大区域主要国家的相关情况进行概述。截至2018年，非洲区域、美洲区域、东地中海区域、欧洲区域、东南亚区域和西太平洋区域约120多个成员国对草药的生产实施监管，其中80多个国家已拥有草药的生产质量管理规范（GMP）体系，且多数国家的草药GMP与常规药品的GMP一致，部分国家采用WHO的GMP指导原则，欧洲区域的多数国家采用欧盟的GMP指导原则。对于草药的安全性评价，通过上述WHO 6大区域主要国家的总结，130多个国家已拥有草药的安全性评价体系，其中多数国家的草药安全性评价体系与常规药品相同，少数国家拥有本国的特定安全性评价体系。世界各国需要根据本国草药的实际应用情况建立完善的草药生产与安全性评价体系。对于草药的销售类型，其多作为处方药、非处方药、自制药进行出售。 |
| English Summary: |
| The globalization of herbal medicines is gaining momentum and has attracted increasing attention.This study focuses on the production，safety evaluation，and sale-type of herbal medicines and summarizes the relevant situations in the major countries of the WHO's six regions.As of 2018，more than 120 member states in the African Region，the Region of the Americas，the Eastern Mediterranean Region，the European Region，the South-East Asia Region，and the Western Pacific Region have regulated the production of herbal medicines.More than 80 countries have already established GMPs for herbal medicines，and most countries' GMPs for herbal medicines are consistent with those for conventional medicines.Some countries adopted the WHO's GMP guidelines.Most countries in the European Region adopt EU GMP guidelines.Regarding the safety evaluation of herbal medicines，we summarized the situations of the major countries in the six regions.More than 130 countries have established the safety evaluation systems for herbal medicines，most of which are similar to those for conventional medicines.A few countries have their own specific herbal safety evaluation systems.Countries need to establish a complete production and safety evaluation system based on the actual application of herbal medicines.As for the sale-types，herbal medicines are mostly sold as prescription，over-the-counter，and home-made medicines. |
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