摘要
细胞与基因治疗是国内外生物医药产业未来发展的主要方向之一。世界各国对细胞与基因治疗产品的监管兼具科学性和地域特色。该文简要介绍了欧盟、美国和日本对细胞与基因治疗的监管体系,并对我国自上世纪90年代开始的监管演变和完善进行了回顾,分析了监管科学研究的进展,提出了面临的挑战和进一步的研究方向。
Cell and gene therapy is among the key future directions of the global biomedical industry.Regulatory frameworks for these products across countries combine scientific rigor with regional characteristics.This articleprovides a brief overview of the regulatory approaches for cell and gene therapy in Europe,the United States,andJapan.It also reviews the evolution and refinement of China’s regulatory system since the 1990s,analyzes progress inregulatory science research,and discusses existing challenges along with potential future research directions.
作者
郭静莉
高建超
卞莲莲
葛思翔
高晨燕
GUO Jingli;GAO Jianchao;BIAN Lianlian;GE Sixiang;GAO Chenyan(Changping Laboratory,Beijing 102206,China)
出处
《中国细胞生物学学报》
2026年第1期20-32,共13页
Chinese Journal of Cell Biology
基金
昌平实验室(批准号:2023C-10-01)资助的课题。
关键词
细胞与基因治疗
监管科学
监管进展
cell and gene therapy
regulatory science
regulatory progress
