国际细胞治疗临床研究发展现状及监管政策研究  

Study on the International Development of Clinical Research and Regulatory Policies on Cell Therapy

作　　者：朱凤昌[1] 叶潇 崇小萌[2] 江翊国 ZHU Feng-chang;YE Xiao;CHONG Xiao-meng;JIANG Yi-guo(Chinese Pharmaceutical Association,Beijing 100050,China;National Institutes for Food and Drug Control,Beijing 100050,China;The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University,Jiangsu Suzhou 215153,China)

机构地区：[1]中国药学会,北京100050 [2]中国食品药品检定研究院,北京100050 [3]南京医科大学附属苏州科技城医院,江苏苏州215153

出　　处：《中国药物评价》2024年第4期257-264,共8页Chinese Journal of Drug Evaluation

基　　金：苏州市科技发展项目(SLT2021002);中国食品药品检定研究院关键技术研究基金(GJJS 2022-9-1)。

摘　　要：细胞治疗作为生物医学领域的前沿热点,其快速的创新发展不仅关乎公众健康,更深刻影响国家的生物安全。欧美、日本等发达国家已将此提升至国家战略高度,并构建了完善的药品监管体系以巩固其在细胞治疗领域的领先地位。本文通过统计分析与研究,全面梳理了全球主要国家及地区和我国的细胞治疗临床研究现状,追踪各国监管体系的演变,并系统整理了关键的规范指南。基于此,初步提出了针对我国细胞治疗产品与技术双轨制监管体系的建议,旨在为相关机构、企业及从业人员提供有价值的参考。Cell therapy,as a cutting-edge hotspot in the biomedical field,its rapid pace of innovation and development not only bears significance for public health but also profoundly impacts national biosafety.Developed countries such as Europe,the United States,and Japan have elevated this to the level of national strategy and established comprehensive drug regulatory systems to consolidate their leading positions in the field of cell therapy.Through rigorous statistical analysis and research,this article comprehensively reviews the current status of cell therapy clinical research in major countries and regions worldwide,tracks the evolution of regulatory systems in Europe,the United States,Japan,and China,and systematically compiles key normative guidelines.Based on these findings,preliminary suggestions for a dual-track regulatory system for cell therapy products and technologies in China are proposed,aiming to provide valuable references for relevant agencies,enterprises,and practitioners.

关 键 词：细胞治疗 临床研究 药品监管科学 技术创新 

分 类 号：R95[医药卫生—药学]