中国食品药品监管Issue(5)：4-13,10.DOI:10.3969/j.issn.1673-5390.2025.05.001
疫苗平台技术的研发应用现状与监管思考
A Review of the Development and Application of Vaccine Platform Technologies and Regulatory Considerations
摘要
Abstract
Vaccine platform technology,as an emerging model for vaccine development,has garnered significant attention due to its ability to rapidly respond to public health emergencies.Currently,several vaccines developed using vaccine platform technologies have been successfully approved and continuously updated,providing robust support in containing outbreaks of emerging infectious diseases and controlling the spread of major epidemics.This paper reviews the definition of vaccine platform technology,compares the recognition standards and regulatory pathways adopted by selected countries and regions,and explores technical considerations in the context of pathogen variation and vaccine strain substitution.Additionally,this paper examines the current landscape of research and development,regulatory practices,and future trends of vaccine platform technologies in China,aiming to provide a scientific reference for related research and regulatory practice.关键词
疫苗/平台技术/药物监管/疫苗株/新发传染病Key words
vaccine/platform technology/drug regulation/vaccine strain/emerging infectious diseases分类
药学引用本文复制引用
潘阳,刘波,邓霞,刘亚琳,苏瑶,鲁爽,王涛..疫苗平台技术的研发应用现状与监管思考[J].中国食品药品监管,2025,(5):4-13,10.基金项目
药品监管科学全国重点实验室课题(2023SKLDRS0146) （2023SKLDRS0146）
