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CFDA发狠,下周开展6省银杏叶药品专项抽验

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发表于 2020-9-9 23:18:34 | 显示全部楼层 |阅读模式
国家药监总局今日发布通知,决定在北京、吉林、江苏、广东、四川、陕西等6省(市)开展银杏叶药品专项监督国家药监总局今日发布通知,决定在北京、吉林、江苏、广东、四川、陕西等6省(市)开展银杏叶药品专项监督","articleBody":"养生之道网导读:国家药监总局今日发布通知,决定在北京、吉林、江苏、广东、四川、陕西等6省(市)开展银杏叶药品专项监督抽验。抽验工作从6月16日开始。此次银杏叶药……国家药监总局今日发布通知,决定在北京、吉林、江苏、广东、四川、陕西等6省(市)开展银杏叶药品专项监督抽验。抽验工作从6月16日开始。此次银杏叶药品专项监督抽验的工作目标是对对市场上在售的所有药品生产企业生产的银杏叶药品实现全覆盖抽验,彻底净化银杏叶药品市场。要求六省对本行政区域内市场上销售的其他省(区、市)药品生产企业生产的银杏叶药品进行抽样。对片剂、胶囊剂,每个企业共抽取20—30批次;对其他剂型,每个企业共抽取3—5批次。抽样量应为检验量的3倍,且至少包含3个最小销售包装。被抽样单位应包括药品批发、零售及使用单位,且有一定的覆盖面和代表性。应均衡抽样,避免重复。以下为通知原文:食品药品监管总局关于开展银杏叶药品专项监督抽验的通知食药监药化监〔2015〕69号北京、吉林、江苏、广东、四川、陕西省(市)食品药品监督管理局,中国食品药品检定研究院:为配合银杏叶药品专项治理工作,进一步查清当前市场上销售的银杏叶药品的质量状况,食品药品监管总局决定在北京、吉林、江苏、广东、四川、陕西等6省(市)开展银杏叶药品专项监督抽验。现就有关事宜通知如下:一、工作目标对市场上在售的所有药品生产企业生产的银杏叶药品实现全覆盖抽验,彻底净化银杏叶药品市场。二、抽样要求(一)请北京、吉林、江苏、广东、四川、陕西省(市)食品药品监管局组织对本行政区域内市场上销售的其他省(区、市)药品生产企业生产的银杏叶药品进行抽样。对片剂、胶囊剂,每个企业共抽取20—30批次;对其他剂型,每个企业共抽取3—5批次。(二)被抽样单位应包括药品批发、零售及使用单位,且有一定的覆盖面和代表性。应均衡抽样,避免重复。(三)抽样量应为检验量的3倍,且至少包含3个最小销售包装。(四)抽样工作从2015年6月16日开始,每天通过“国家药品抽验信息系统”上传抽样进度,全部抽样工作应于2015年6月25日前完成,并向食品药品监管总局报告抽样汇总情况(填报附件)。三、检验要求(一)对抽取的银杏叶分散片、银杏叶片和银杏叶胶囊,请各相关省(市)食品药品监管局组织本省(市)食品药品检验所根据《银杏叶提取物、银杏叶片、银杏叶胶囊中游离槲皮素、山柰素、异鼠李素检查项补充检验方法》进行检验。相关省(市)食品药品检验所对收到的样品应立即安排检验,并每天通过“国家药品抽验信息系统”上传检验结果。(二)对抽取的其他剂型的银杏叶药品,请寄送至中检院综合业务处(北京市东城区天坛西里2号,邮编100050)。请中检院利用抽取的样品抓紧对补充检验方法的适用性进行复核,并对相关样品进行检验。(三)食品药品监管总局将于2015年6月26日开始,陆续向社会发布检验的结果,请各省(市)食品药品检验所每天按时上传检验数据。四、其他要求(一)抽验药品应为2014年1月1日之后生产的产品。(二)为保障专项抽验工作顺利实施,食品药品监管总局为北京、吉林、江苏、广东、四川、陕西等6省(市)分别临时增配“国家药品抽验信息系统”密钥5把。请各省(市)食品药品监管局务必严格使用、妥善保管。专项抽验工作结束后,请于2015年6月30日前将增配的密钥寄回食品药品监管总局药化监管司(北京市西城区宣武门西大街26号院2号楼,邮编100053)。(三)补充检验方法在执行中有何问题,请与中检院联系,中检院应安排专人负责此项工作。(四)此次专项检验所需经费由食品药品监管总局承担,各省(市)食品药品监管局先行垫付。有没有人说白癜风终于治好了
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