中国疫苗的技术审评体系及质量状况分析  

Overview of the vaccine quality and regulation requirements in China

作　　者：高恩明[1] 李敏[1] 尹红章[1] 罗建辉[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2014年第8期912-914,共3页Chinese Journal of New Drugs

摘　　要：近年来SARS、禽流感、手足口病等一些新发、突发传染病疫情的爆发,使疫苗的研发和使用受到国内外广泛关注。疫苗技术审评是疫苗上市注册的重要环节。本文对我国疫苗技术审评及其质量管理体系进行介绍,并以代表性疫苗为例,回顾分析在我国进口注册或上市生产疫苗的质量状况,藉以了解我国疫苗的技术审评体系及疫苗质量基本状况。Due to the epidemics of emergening infectious diseases such as SARS, H1N1 influenza, hand, foot and mouth disease etc. in recent years, vaccine quality and regulation requirements had arose many concerns in China and abroad. In this paper, we present a brief introduction of the scientific review processes, and its quality management system. In addition, the quality of the representive vaccines which have been approved on market in China. has been highlighted by comparison of the manufacturing process and registration specifications between do- mestic and imported vaccines. Hopefully, this information will help catching on a clear picture of the overall condi- tion of vaccine quality and regulation in China.

关 键 词：疫苗 技术审评 生产工艺 质量标准 

分 类 号：R95[医药卫生—药学]