健康发展与政策研究2024，Vol.27Issue(5)：382-389,8.DOI:10.12458/HDPR.202405026
国内外嵌合抗原受体T细胞治疗产品监管体系情况探讨
Comparative analysis of domestic and international regulatory systems for chimeric antigen receptor T cell products
摘要
Abstract
Recent years witnessed the surge of chimeric antigen receptor (CAR) T cell therapy in China to meet the great market demand.As of May 2024,there are 11 CAR-T cell products available globally,with five approved by the National Medical Products Administration(NMPA) of China.China has emerged as a global leader in CAR-T cell therapy research and development,particularly in terms of the number of patent applications and clinical trials.With the ongoing accumulation of experience and deeper exploration,the authorities in China have established a three-tier regulatory system of laws,regulations and guidelines that cover the entire life cycle of CAR-T cell products,from research and development to registration,production,and post-marketing surveillance.Nevertheless,there remain gaps when compared to the regulatory systems in countries and regions such as the United States,the European Union,and Japan.This paper examines the development of the CAR-T cell therapy industry in China,and introduces the regulatory practices of the United States,the European Union,and Japan,in order to provide recommendations for the regulatory system improvement for CAR-T cell products in China.关键词
嵌合抗原受体T细胞/产业发展现状/监管体系Key words
chimeric antigen receptor T cell/industry development/regulatory system分类
医药卫生引用本文复制引用
安小通,孙红玉,刘艳君,高雯,孙郡,胡晓静..国内外嵌合抗原受体T细胞治疗产品监管体系情况探讨[J].健康发展与政策研究,2024,27(5):382-389,8.基金项目
山东省医药卫生科技发展计划(202203010420) （202203010420）
济南市卫生健康委员会科技计划(2023-1-34) （2023-1-34）
