新冠体外诊断试剂国内外监管差异及其根源分析  

Comparative Analysis on Differences and Causes of Regulating COVID-19 In Vitro Diagnostic Reagents

作　　者：顾林昊 李丽莉[2] 戴珒 Gu Linhao;Li Lili;Dai Jin(School of Life Science and Technology,Shanghai Tech University,Shanghai 201210,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]上海科技大学生命科学与技术学院,上海201210 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2023年第2期142-149,共8页Chinese Pharmaceutical Affairs

基　　金：北京市科技计划——创新品种及平台培育项目——新冠肺炎诊断试剂科技攻关技术平台(编号Z201100005420022)。

摘　　要：目的:探讨新冠体外诊断试剂监管与公共卫生政策的关系,从监管科学角度总结我国防控新冠疫情的经验,为应急监管体系的持续改进提供参考。方法:比对中、美、欧盟、WHO这几个主要国家或组织的审评流程、审评要求、产品数据等,并分析差异原因。结果与结论:各国(组织)在新冠疫情中对于新冠体外诊断试剂的监管与其自身国情相关,尤其是产品应用场景方面的差异。我国对体外诊断试剂的监管与公共卫生政策密切关联,在对抗新冠疫情中起到了积极作用。Objective:To explore the relationship between the regulations of COVID-19 in-vitro diagnostic(IVD)reagents and public health practices,summarize the experience of fi ghting the COVID-19 from a regulatory science perspective and provide reference for continually improving the emergency regulation system.Methods:The approval procedures,requirements and product data of different countries/organizations and the reasons for differences were analyzed.Results and Conclusion:The supervisions of these IVD products in different countries/organizations are consistent with the diff erent conditions especially the context diff erences of product application.The supervision of IVD reagents in China is closely related to public health policies and has played a positive role in fi ghting against COVID-19.

关 键 词：新型冠状病毒肺炎 体外诊断试剂 差异来源分析 防疫政策 审批流程 审评要求 

分 类 号：R95[医药卫生—药学]