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<section powered-by="gulangu"><section><section powered-by="gulangu"><section><section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br /></p><section data-tools="gulangu" data-id="708" data-color="#f5f5f4" data-custom="#f5f5f4"><section><p><p><img src="image/20201014/f9416b10b7bfe58af00d19d54ca74937_2.png" /></p></p><p><br /></p><p><span>2月25日，国务院联防联控机制举办新闻发布会，介绍维护市场秩序、支持复工复产相关情况，并答记者问。国家药品监督管理局副局长颜江瑛出席发布会并表示，疫情发生以来，国家药监局紧急开辟药品医疗器械应急审批绿色通道，各省级药监部门指导企业合理安排生产，充分释放产能，全力支持临床供应。截至2月24日，医用防护服日产量已达到33万套，医用防护口罩日产量达到84.4万个，核酸检测试剂产能每日可达到170万人份，抗体检测试剂产能每日可达到35万人份。</span></p><p><span><br /></span></p><p><span>按照党中央、国务院关于切实加强疫情科学防控、有序做好企业复工复产工作的部署，2月15日，国家市场监管总局会同国家药监局、国家知识产权局发布了《支持复工复产十条》，充分发挥职能作用，解决企业复工复产中面临的实际问题。其中明确要求对疫情所需药品、医疗器械要建立行政许可应急绿色通道。</span></p><p><span><br /></span></p><p><span>发布会上，颜江瑛介绍，国家药监局采取了多项措施保障应急防控物资需要以及防疫所需的药品和医疗器械。一是制定药品和医疗器械应急审批工作方案，建立了有关审批工作机制，组建了药品医疗器械应急审批特别专家组，科学有序开展工作。二是加快审评审批，推动产品尽早上市用于防疫需要。对疫情防控所需的药品注册申请，在确保产品安全性和有效性基础上，加快审评审批；对于医用口罩、医用防护服等医疗器械产品的注册、生产许可和检验检测等实施特别措施，合并审批流程；对于转产生产医疗器械的企业实行应急审批，依法办理医疗器械注册证和生产许可证，全力满足防疫所需。三是及时服务企业，扩大产能。药监部门加强对企业的指导，对疫情防控相关药械生产企业开展“一对一”服务，提供全程咨询、技术支持和政策指导。对疫情防控所需药品，各省级药监部门指导企业合理安排生产，充分释放产能。为降低企业负担，对进入医疗器械应急审批程序且与新冠肺炎相关的防控产品，以及进入药品特别审批程序且与治疗和预防新冠肺炎有关的药品，均免征注册费用。</span></p><p><span><br /></span></p><p><span>据介绍，当前国家药监局已应急审批了瑞德西韦、法匹拉韦等5个新药用于新冠肺炎防治的临床试验；在前期应急批准7家企业的核酸诊断试剂基础上，2月22日，国家药监局又应急批准了3个诊断试剂产品，其中两个是胶体金法的抗体检测试剂，一个是恒温扩增芯片法的核酸检测试剂，进一步满足了一线的快速检测需求。截至2月24日，全国共有医用防护服医疗器械注册证134个，其中在防疫期间应急审批的是93个；共有医用防护口罩的注册证84个，其中应急审批21个；共有医用外科口罩注册证225个，其中应急审批67个；共有一次性使用医用口罩注册证396个，其中应急审批65个。</span></p><p><span><br /></span></p><p><span>颜江瑛表示，为把好药品和医疗器械质量关，国家药监局始终坚持“安全守底线，疗效有证据，质量能保证，审评超常规”的应急审批原则，同时对应急审批药械加强上市后监管，对卫健委的诊疗方案中提到的药品，也加强监管。一是严守质量安全底线，强化疫情防控药械的监督检查，特别是针对应急审批的产品，加大检查和抽检力度，对医用防护服等疫情防控急需的药械生产企业实行驻厂监督。二是及时派出督查组，强化疫情防控重点产品的监管，加大与工信部门、市场监管部门的协作，加强对定点企业监督检查。目前国家药监局已派出了两批13个工作组和地方药监部门一起，对疫情防控所需要的药品、医疗器械，加大监督检查，督促企业严格自律，确保产品的质量安全。三是严厉打击违法犯罪行为，积极会同公安、卫生健康、市场监管等部门，依法从严、从重、从快查处药品医疗器械违法犯罪行为。</span></p><p><span><br /></span></p><p><span>颜江瑛强调，下一步，国家药监局将继续抓好疫情防控所需要的药品医疗器械应急审批工作，督促各省级药监部门深入落实疫情防控工作要求，加强对转产扩产企业的指导、服务和监管，大力支持企业复工复产，全力保障疫情防控所需药械质量安全。</span></p><p><br /></p><p><span>来源:国家药监局</span></p><section><br /></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br /></section></section><section 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发表于 2020-10-14 12:52:28