《溶瘤病毒产品药学研究与评价技术指导原则(试行)》解读  

Interpretation of Guidance on CMC Study and Evaluation Techniques of Oncolytic Virus Products(Trial)

作　　者：崔靖 韦薇[1] 何伍[1] CUI Jing;WEI Wei;HE Wu(Center for Drug Evaluation,National Medical Products Administration)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2023年第5期24-31,共8页China Food & Drug Administration Magazine

摘　　要：近年来,随着技术的不断发展和研究的不断深入,溶瘤病毒产品对肿瘤细胞的选择性和有效性不断提高,对正常细胞的影响进一步降低,产品的安全性稳步提升,逐步成为国内外研发热点。为鼓励和促进溶瘤病毒产品的发展,国家药品监督管理局药品审评中心于2023年2月13日正式发布了《溶瘤病毒产品药学研究与评价技术指导原则(试行)》。本文结合指导原则制定背景,对指导原则内容和重点问题进行详细解读,以供业界更好的理解和运用指导原则技术要求,进一步促进国内溶瘤病毒产品研发和申报规范性。In recent years,with the continuous development of technology and research,the selectivity and effectiveness of oncolytic virus products in targeting tumor cells have been improving,while their impact on normal cells has been reduced.The safety of these products has steadily increased,making them a research and development hotspot around the world.To encourage and facilitate the development of oncolytic virus products,the Center for Drug Evaluation of the National Medical Products Administration officially issued the Guidance on CMC Study and Evaluation Techniques of Oncolytic Virus Products(Trial)on February 13,2023.This paper provides a detailed interpretation of the main content and some important issues of the guidance,combined with the drafting background,aiming to provide the industry with a better understanding and application of the technical requirements specified in the guidance and promote the standardization of oncolytic virus products development and application in China.

关 键 词：溶瘤病毒产品 药学研究 解读 

分 类 号：R95[医药卫生—药学]