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    2020年我国医疗器械应急审批报告

    摘要

    为满足新冠肺炎疫情防控需求,2020年,国家药监局启动医疗器械应急审批工作,各级药品监督管理部门应急审批通过了体外诊断试剂、防护服、各类防护口罩等多种疫情防控产品,应急批准时间、产品数量均充分满足了疫情防控工作的需要,并发挥了关键性的作用,为打赢疫情防控阻击战提供了有力保障。在应急审批工作中,国家药监局创新举措,通过并联审查、随到随审,提升速度;通过附条件批准、限定许可效期,提高效率;通过信息系统保障,确保连续审查和持续的指导;通过上市前后联动,确保了上市产品的质量持续可控。本文对相应应急审批工作进行了全面回顾,并对有关问题进行总结分析,在此基础上,对下一步工作包括应急审批程序的完善、条例相关紧急使用要求等进行了分析。

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    Abstract

    At the end of 2019,COVID-19 pandemic outbroke,NMPA launched the emergency approval procedure for medical device,in order to deal with the different Emergency Public Health Incidents,NMPA and local MPA emergency approved some IVD,PPE,medical mask and so on. The emergency approval time and product quantity fully meet the needs of epidemic prevention and control. During the work of emergency approval,NMPA has taken innovative measures to improve the speed through parallel review and on-going review,improve the efficiency through conditional approval and limiting the validity period of license,ensure continuous review and continuous guidance through information system,and ensure the continuous controllable quality of products through the joint action Pre and post market. Based on a comprehensive review of the corresponding emergency approval work and analysis of the relevant problem,this article thinks about the next step,including the improvement of the emergency approval procedures and the relevant emergency use requirements of the regulations.

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    作者简介
    袁鹏:袁鹏,国家药品监督管理局医疗器械注册管理司注册一处处长。
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