中国食品药品监管Issue(12)：134-141,8.DOI:10.3969/j.issn.1673-5390.2025.12.014
CAR-T产品研究进展及中美监管政策浅析
Research Progress of CAR-T Products and a Brief Analysis of Regulatory Policies between China and the United States
SUN Qing-yang 1LIANG Yi1
作者信息
- 1. School of International Pharmaceutical Business,China Pharmaceutical University
- 折叠
摘要
Abstract
Chimeric antigen receptor T-cell(CAR-T)therapy,as a novel precision-targeted anti-tumor approach in the biopharmaceutical field,has achieved breakthrough progress in the treatment of malignant tumors in recent years.Alongside its rapid global development,regulatory policies governing CAR-T products have been continuously refined.This article systematically reviews the research progress of CAR-T products and summarizes their current status in terms of research and development strategies,quality control,and regulatory frameworks,aiming to provide a reference for the standardized development of cellular immunotherapy.Furthermore,by analyzing major regulatory policies in China and the United States,this paper seeks to offer a more diverse perspective for industry stakeholders.Building on this analysis,future research directions and regulatory considerations are further proposed to promote the healthy and sustainable development of the cell therapy field.关键词
嵌合抗原受体T细胞/研究进展/质量控制/监管法规/监管政策Key words
chimeric antigen receptor T-cell/research progress/quality control/regulatory framework/regulatory policies分类
管理科学引用本文复制引用
SUN Qing-yang,LIANG Yi..CAR-T产品研究进展及中美监管政策浅析[J].中国食品药品监管,2025,(12):134-141,8.
