疫苗国家监管体系评估的警戒板块要求浅析与启示  

Requirements of Vaccine Vigilance Function from NRA Assessment

作　　者：于一 王亚丽 YU Yi;WANG Yali(Center For Drug Reevaluation,NMPA,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品评价中心,北京100022

出　　处：《中国药物警戒》2021年第4期324-327,共4页Chinese Journal of Pharmacovigilance

摘　　要：疫苗国家监管体系(NRA)在确保疫苗的质量、安全性和有效性方面发挥着重要作用,同时一个国家通过世界卫生组织(WHO)的NRA评估是该国疫苗生产企业获得WHO预认证(PQ)资格的必要条件。我国于2021年迎来新一轮NRA评估。本文介绍了NRA评估整体情况,结合我国疫苗警戒工作现状对NRA评估的警戒板块指标要求进行了分析,并在此基础上提出促进我国疫苗警戒工作的建议。The national regulatory system(NRA)plays an important role in ensuring the quality,safety and effectiveness of vaccines.At the same time,vaccine manufacturers in a country have to pass the NRA evaluation by the World Health Organization(WHO)to obtain the prequalification(PQ)of vaccines.China will undergo a new round of NRA evaluation in 2021.In this paper,the NRA evaluation was introduced.Combined with the status quo of vaccine vigilance in China,the indicators of vigilance function of NRA evaluation were analyzed.On this basis,ways to promote vaccine vigilance in China were recommended.

关 键 词：疫苗 世界卫生组织 国家监管体系 警戒 疑似预防接种异常反应 

分 类 号：R994.11[医药卫生—毒理学]