国家药监局召开“4+7”集采中标品种监管工作调度会

2019-03-14 佚名 新浪医药新闻  

3月13日,据国家药品监督管理局官网消息,近日,国家药监局召开“4+7”集采中标品种监管工作调度会,进一步贯彻落实党中央国务院关于药品集中采购和使用试点工作部署,研究部署通过仿制药一致性评价药品、特别是“4+7” 集采中标品种的监管工作,全力保障药品质量安全。


3月13日,据国家药品监督管理局官网消息,近日,国家药监局召开“4+7”集采中标品种监管工作调度会,进一步贯彻落实党中央国务院关于药品集中采购和使用试点工作部署,研究部署通过仿制药一致性评价药品、特别是“4+7” 集采中标品种的监管工作,全力保障药品质量安全。

会议指出,要充分认识做好“4+7”集采中标品种和通过一致性评价的药品监管工作的重要意义。药品集中采购和使用试点是党中央国务院的重要决策部署,是深化医改、解决看病难看病贵问题的重大举措。药品监管部门必须提高认识,认真贯彻党中央国务院的决策部署,把“4+7”集采中标品种的监管作为当前一项重要工作任务来抓,切实增强人民群众安全用药的获得感。

会议强调,各级药品监管部门要加强全链条、全生命周期监管,加强对中标企业执行GMP、GSP等各项规范的检查,加强中标品种原辅包材的延伸检查。各地监管人员要牢固树立风险意识,处理好服务产业发展和监管的关系,严守质量安全底线。

会议要求,一是要全面落实企业主体责任,企业要严格按照一致性评价通过的标准和要求组织生产,落实全生命周期质量责任,切实保障药品质量安全。二是要切实落实监管责任,结合各地监管实际,细化分工,落实责任,切实做好中标品种和通过一致性评价品种生产、流通、使用环节的监管工作。三是要积极配合有关部门做好供应保障工作,积极支持企业兼并重组、联合发展,保障药品供应和人民群众用药可及。四是要以“4+7”集采中标品种监管为抓手,探索建立通过一致性评价品种的长效监管措施。

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    2019-07-23 xsm929
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    2019-03-16 xuyu
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    2019-03-16 wwzzly
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    2019-03-15 飛歌

    学习了很有用不错

    0

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