疫苗国家监管体系评估的警戒板块要求浅析与启示

doi:10.19803/j.1672-8629.2021.04.06

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (4): 324-327.
DOI: 10.19803/j.1672-8629.2021.04.06

疫苗国家监管体系评估的警戒板块要求浅析与启示

于一, 王亚丽^*

国家药品监督管理局药品评价中心,北京 100022

收稿日期:2020-05-27 出版日期:2021-04-15 发布日期:2021-04-23
通讯作者: ^*王亚丽,女,博士,副主任药师,药品不良反应监测与评价。E-mail：wangyali@cdr-adr.org.cn
作者简介:于一,女,硕士,工程师,药品不良反应监测与评价。

Requirements of Vaccine Vigilance Function from NRA Assessment

YU Yi, WANG Yali^*

Center For Drug Reevaluation, NMPA, Beijing 100022, China

Received:2020-05-27 Online:2021-04-15 Published:2021-04-23

摘要/Abstract

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。

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

Abstract: 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.

Key words: vaccine, WHO, NRA, vigilance, AEFI

中图分类号:

R994.11

于一, 王亚丽. 疫苗国家监管体系评估的警戒板块要求浅析与启示[J]. 中国药物警戒, 2021, 18(4): 324-327.

YU Yi, WANG Yali. Requirements of Vaccine Vigilance Function from NRA Assessment[J]. Chinese Journal of Pharmacovigilance, 2021, 18(4): 324-327.

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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

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