中国医学伦理学2026，Vol.39Issue(5)：557-564,8.DOI:10.12026/j.issn.1001-8565.2026.05.01
ICH《E6(R3):药物临床试验质量管理规范技术指导原则》变化亮点和主要修订内容
Highlights of changes and major revisions in E 6(R 3):Guideline for Good Clinical Practice of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
摘要
Abstract
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)issued the ICH E 6(R 3):G uideline for Good Clinical Practice on January 14,2025,which will enhance the speed and quality of global clinical trials,including those in China.As the ethical,scientific and quality standards for global drug clinical trials,the highlights of the revision in the ICH E6(R3)include encouraging innovation to improve efficiency and quality,motivating research participants to participate in the design and implementation of clinical trials throughout the process,emphasizing quality originating from design and based on the quality management of risks,as well as underlining proportionality and standalone chapter to data governance.ICH E6(R3)adopts an appendix and appendix structure,enabling future revisions to be more convenient and efficient.ICH E6(R3)restructures the principles section,adding two new principles and reducing the total from 13 to 11,while incorporating extensive explanatory notes.Major revisions also encompass multiple aspects,including regular review by ethics committees to ensure the safety,rights and interests,and well-being of research participants;diversification of informed consent methods,refinement of its processes,and clarification of detailed rules for minors'consent;qualifications,authorization,and oversight of investigators and their service providers;risk-proportionate design and implementation by sponsors;joint data governance by investigators and sponsors;and the addition and revision of terms,along with updates to three appendices.The design,implementation,and review of drug clinical trials in China are increasingly aligning with international standards.ICH E6(R3)will accelerate the revision of China's Guideline for Good Clinical Practice,promote the speed and quality of drug research and development,and further facilitate the internationalization of China's new drug research and development.关键词
药物临床试验质量管理规范/医学伦理/伦理委员会/新药Key words
guideline for good clinical practice/medical ethics/ethics committee/new drug分类
医药卫生引用本文复制引用
张亚美,何芹,周吉银..ICH《E6(R3):药物临床试验质量管理规范技术指导原则》变化亮点和主要修订内容[J].中国医学伦理学,2026,39(5):557-564,8.基金项目
2022年陆军军医大学人文社会科学基金重点项目"我市涉及人的健康相关研究伦理治理的现状与对策研究"(2022XRW02) （2022XRW02）
