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target="_blank">合理用药</a> </div> </div> <div class="i2i2jyu4k" id="content"> <div id="i2i2jyu4k" class="pv_box m_p ov_hi"> <div id="i2i2jyu4k" class="bw_750 fl"> <h1 class="pv_title_2"><span id="i2i2jyu4k" class="site fr"><a href='/'>首页</a>><a href='/xywy/'>寻医·问药</a>><a href='/xywy/yxtqs/'>医讯同期声</a></span><span id="i2i2jyu4k" class="t" id="a1"><a href="/xywy/yxtqs/">医讯同期声</a></span></h1> <div id="i2i2jyu4k" class="pa_0_5_0_10"> <h1 class="Content_title" id="hh"> <span id="a" style="">服役8年的药品电子监管码为何被叫停</span> </h1> <script>/*jQuery('#hh').width(jQuery('#a').width());*/</script> <div id="i2i2jyu4k" class="Remark"> <span>2016年02月23日 08:51 | 来源：<a target="_blank">经济日报</a></span> <span id="i2i2jyu4k" class="fr"> <div id="i2i2jyu4k" class="jiathis_style_24x24"> <a class="jiathis_button_qzone"></a> <a class="jiathis_button_tsina"></a> <a class="jiathis_button_tqq"></a> <a class="jiathis_button_weixin"></a> <a class="jiathis_button_renren"></a> <a class="jiathis jiathis_txt jtico jtico_jiathis" target="_blank"></a> </div> <script type="text/javascript" src="http://v3.jiathis.com/code_mini/jia.js?uid=1399539302485450" charset="utf-8"></script> </span><span id="i2i2jyu4k" class="fr">分享到：<img src="/images/fx.jpg" /> </span> </div> <div id="i2i2jyu4k" class="text_box"> <p align="center"> <p style="text-indent: 2em; text-align: left;">近日，国家食品药品监督管理总局发布公告，暂停执行药品电子监管的有关规定，同时就《药品经营质量管理规范》（修订草案）向社会公开征求意见。至此，服役了8年的药品电子监管制度被叫停。</p><p style="text-indent: 2em; text-align: left;">从草案的修订内容来看，取消了强制执行电子监管码扫码和数据上传的要求，删除了“对实施电子监管的药品，企业应当按规定进行药品电子监管码扫码，并及时将数据上传至中国药品电子监管网系统平台”，以及“对实施电子监管的药品，在售出时，应当进行扫码和数据上传”。同时，将“执行药品电子监管的规定”修改为“执行药品追溯的规定”。</p><p style="text-indent: 2em; text-align: left;">据了解，药品电子监管码，是药品包装上的20位数字的条形码，可以实现药品从生产到流通各个环节的全程跟踪。今年1月，食品药品监管部门就曾通过药品电子监管码发现了7家企业非法回收药品。</p><p style="text-indent: 2em; text-align: left;">不可否认，多年来药品电子监管码暴露的问题并不少，其中，药品企业投入成本引发的争议最多。据了解，拥有540多家门店的湖南养天和大药房在接受药品电子监管码后，需要购买的扫码枪、密匙以及后续维护，首期投入费用就高达1200万元。同时，不少药企也认为，阿里健康独家运营中国药品电子监管网，公平竞争、信息安全等问题也无法得到保证。</p><p style="text-indent: 2em; text-align: left;">“此次公告既落实了国务院加强产品追溯体系建设要求，又充分考虑了行业对实施电子监管码的意见和诉求?！惫沂骋┘嘧芫窒喙馗涸鹑吮硎荆ü喙胤煞ü娴耐晟?，将大力推动历史遗留问题的解决。</p><p style="text-indent: 2em; text-align: left;">有业内人士担忧，如果电子监管码就此完全取消，药品安全监管是否会受到影响？事实上，暂停了药品电子监管码，并不意味着药品追溯制度的缺失。</p><p style="text-indent: 2em; text-align: left;">《药品经营质量管理规范》修订草案指出，药品经营企业应当按照国家有关要求建立药品追溯制度，实现药品来源可查、去向可追、责任可究。同时，企业应当建立能够符合经营全过程管理及质量控制要求的计算机系统，实现药品质量可追溯?！翱梢钥闯觯乱徊?，药品追溯体系将替代电子监管码，承担起对药品监管的职责?！惫沂骋┘嘧芫钟泄馗涸鹑怂怠?/p><p style="text-indent: 2em; text-align: left;">去年底，国务院印发的《关于加快推进重要产品追溯体系建设的意见》明确要求以落实企业追溯管理责任为基础，强化企业主体责任，建设来源可查、去向可追、责任可究的重要产品追溯体系。而现行的药品电子监管码制度主要是靠食品药品监管部门推动。今后，药品追溯体系建设将由企业为主，监管部门只负责给予必要指导。</p><p style="text-indent: 2em; text-align: left;">可以肯定，电子监管码退出历史舞台已成定局，但后续药品监管措施还有待完善。业内人士认为，监管部门应及时总结实施电子监管码的经验教训，完善配套技术手段，达到可追溯和监管的双重目标。</p><p><br style="text-indent: 2em; text-align: left;"/></p> </div> <p class="Editor">编辑：赵彦 </p> <div id="i2i2jyu4k" class="Paging"> </div> <p class="Keyword">关键词：药品电子监管码药品追溯</p> <h1 class="pv_title_2 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