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细胞和基因治疗产品现状与我国监管政策研究

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细胞和基因治疗产品在许多无法治愈的疾病领域(例如恶性肿瘤、遗传病等)取得了重大进展.近年来,随着我国各项政策的审慎出台,细胞和基因治疗产品的监管框架逐步清晰,企业管理日趋严格,并走出了一条科学、规范、健康的发展之路.本文简要介绍了细胞和基因治疗产品的国内外临床应用及产业现状、我国监管政策发展和技术评价研究成果,探讨了我国发展细胞和基因治疗产品面临的挑战,并提出针对性建议,以期为我国细胞和基因治疗产品发展提供参考.
Current Status of Cell and Gene Therapy Products and Research on Regulatory Policies in China
Cell and gene therapy products have made significant progress in addressing many incurable diseases fields,such as malignant tumors and genetic diseases.In recent years,with the strict and prudent introduction of various national and local industrial policies,the regulatory framework for cell and gene therapy products has gradually become clearer,leading to stricter enterprise management.China's cell and gene therapy industry has embarked on a path of scientific,standardized and healthy development.This article provides a brief overview of the clinical application and industrial status of cell and gene therapy products home and abroad,the development of regulatory policies and research results of technical evaluation in China.It discusses the challenges faced by the development of the cell and gene therapy products in China,and proposes targeted suggestions to provide reference for its future development.

cell and gene therapy productsclinical applicationindustry statusregulatory policieschallenges

史海涛、谢正福、何本霞、邹毅

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国家药品监督管理局药品审评检查大湾区分中心

广东省药品监督管理局审评认证中心

细胞和基因治疗产品 临床应用 产业现状 监管政策 面临挑战

广东省药品监督管理局科技创新项目

2021TDZ07

2024

中国食品药品监管
中国医药报社

中国食品药品监管

影响因子:0.099
ISSN:1673-5390
年,卷(期):2024.(6)