世界卫生组织体外诊断产品资格预认证项目发展历程及现状

The History and Status of the World Health Organization Pre-Qualification of In Vitro Diagnostics

胡晋君 ¹麻婷婷 ¹刘东来 ¹宋爱京 ¹许四宏 ¹张河战 ¹张辉²

扫码查看

作者信息

1. 中国食品药品检定研究院国家药品监督管理局医疗器械质量研究与评价重点实验室国家药品监督管理局体外诊断试剂质量研究与评价重点实验室
2. 中国食品药品检定研究院
折叠

摘要

世界卫生组织资格预认证(WHO PQ)是WHO向联合国儿童基金会提供的一项服务,用于评估候选疫苗的可接受性,为基金会购买符合一定标准的疫苗提供建议.目前已经涵盖4类产品,即疫苗、药品、体外诊断产品及病媒控制产品,其中体外诊断产品资格预认证(PQDx)是针对体外诊断产品的审评机制,为采购合适的诊断试剂提供科学依据.本文重点介绍了WHO PQDx的历史与发展现状,并以此探讨我国体外诊断制造商申请WHO PQDx的机遇与挑战.

Abstract

The World Health Organization Prequalification(WHO PQ)program,a service provided by the WHO to the United Nations Children's Fund(UNICEF),assesses the acceptability of candidate vaccines and provides recommendations for purchasing vaccines that meet specific criteria.This program currently encompasses four categories of products:vaccines,medicines,in vitro diagnostics,and vector control products.The prequalification of in vitro diagnostic product(PQDx)is a review mechanism specific to in vitro diagnostic products,providing a scientific foundation for the procurement of suitable diagnostic reagents.This article focuses on the history and current status of WHO PQDx,and discusses the opportunities and challenges faced by China's in vitro diagnostic manufacturers in applying for WHO PQDx.

关键词

世界卫生组织/资格预认证/体外诊断产品/历史/发展现状

Key words

World Health Organization/prequalification/in vitro diagnostics/history/development status

引用本文复制引用

出版年

2024

中国食品药品监管

中国医药报社

中国食品药品监管

影响因子：0.099

ISSN：1673-5390

参考文献量1

段落导航