摘要
随着人口老龄化和慢病负担的加重,再生医学研究发展迅速,细胞治疗药品经过长期发展和逐渐成熟,已经成为再生医学研究的重要分支。本文介绍了全球主要监管机构对再生医学治疗药品的监管框架,并基于多年的审评经验积累,对我国细胞治疗药品监管的药学技术要求进行重点说明,另外还提出了对其他基于细胞的再生医学治疗药品药学技术要求的思考和展望,旨在有效促进并加快此类药品的创新和高质量发展。
With the aging of population and increasing burden of chronic diseases,the development of regenerative medicine research has accelerated.Cell therapy medicinal products(CTMP),after a long-term development and gradual maturation process,have become an important branch of regenerative medicine research.This article mainly introduces the regulatory frameworks for regenerative medicine therapeutic drugs in major regulatory agencies around the world,as well as the pharmaceutical technical requirements for CTMP in China.It also brings thoughts and prospects on the pharmaceutical technical requirements for other cell-based regenerative medicine therapeutic drugs,with the aim of effectively promoting and accelerating the innovative and high-quality development of such drugs.
作者
韩冬梅
董静
韦薇
HAN Dong-mei;DONG Jing;WEI Wei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)
出处
《中国新药杂志》
北大核心
2025年第24期2605-2609,共5页
Chinese Journal of New Drugs
关键词
再生医学
细胞治疗药品
药学技术要求
regenerative medicine
cell therapy medicinal products
pharmaceutical technical requirements
