摘要
2022年5月,《免疫细胞治疗产品药学研究与评价技术指导原则(试行)》对外发布,为免疫细胞治疗产品的药学研究和评价提供了指导性建议。本文结合指导原则的起草背景和免疫细胞治疗产品的特点,对该指导原则进行解读,以方便读者更好地理解相关技术要求。
A guidance on CMC study and evaluation of immune cell therapy products was issued by CDE,NMPA on May 2022 in order to illustrate criteria on CMC research and evaluation of such products.This paper provides a detailed interpretation of the guidance,combined with the guidance drafting background and characteristics of immune cell therapy products,to help readers better understand the content of the guidance.
作者
杨菲
韩冬梅
何伍
YANG Fei;HAN Dong-mei;HE Wu(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2023年第2期123-127,共5页
Chinese Journal of New Drugs
