现代医院2026，Vol.26Issue(5)：727-731,5.DOI:10.3969/j.issn.1671-332X.2026.05.006
美国细胞与基因治疗产品监管制度的反思与镜鉴
Reflections on and lessons from the U.S.regulatory framework for cell and gene therapy products
雷娟 1许齐1
作者信息
- 1. 南方医科大学卫生管理学院 广东 广州 510515
- 折叠
摘要
Abstract
Cell and gene therapy(CGT)products are highly innovative and technically complex medical interventions,and the design of their regulatory pathways is critical for the healthy development of the industry.As a country that pioneered such research and clinical applications,the United States has established a full-lifecycle regulatory model characterized by flexibility and safety.However,the convening of the Washington CGT Roundtable suggests that China's current regulatory framework dem-onstrates advantages in promoting innovation and improving review efficiency.Nevertheless,there remains room for improvement in China's existing CGT regulatory system.While drawing lessons from the U.S.experience,it is also necessary to critically e-valuate its limitations,taking into account China's stage of industrial development and local context,and strive to build a clear,coherent,and predictable regulatory pathway.关键词
细胞与基因治疗产品/全生命周期监管/双轨制监管Key words
Cell and gene therapy products/Full-lifecycle regulation/Dual-Track regulatory system分类
医药卫生引用本文复制引用
雷娟,许齐..美国细胞与基因治疗产品监管制度的反思与镜鉴[J].现代医院,2026,26(5):727-731,5.
