临床试验造假，6个医疗器械注册项目被毙

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                    <p>医药网讯　2017年1月5日，北京市药监局发布公告，6个医疗器械注册申请项目的临床试验存在真实性问题，被不予注册，且自不予注册之日起一年内不予再次受理。</p><p>&nbsp;</p><p><strong>　　这6</strong><strong>个注册项目及其各自存在问题如下：</strong></p><p>&nbsp;</p><p>　　 （一）德迈基生物技术（北京）有限公司的5个体外诊断试剂产品</p><p style="text-align: center;"><img data-s="300,640" data-type="jpeg" src="http://mmbiz.qpic.cn/mmbiz_jpg/dx3KibwtDhveyKaibu93xbiax1khoxLVSgHFy46DmYzSbBo1XxibWGBz0VwRvblFE45Y5ut2uT9br7nZWk315lwJEw/0?wx_fmt=jpeg" data-ratio="1.5391061452513966" data-w="358"  /></p><p>在对新乡医学院第三附属<strong><span style="color: rgb(0, 153, 102);">医院</span></strong>开展的上表中5个产品临床试验检查中发现：</p><p>&nbsp;</p><p>　　1、病例未按照统计学原理进行选取，且抽查病例的干扰病例指标无法溯源；</p><p>&nbsp;</p><p>　　2、无证据证明临床试验检测样本涵盖全血样本；</p><p>&nbsp;</p><p>　　3、抽查的病例信息无法在院内LIS系统中追溯。</p><p>&nbsp;</p><p>　　 （二）北京中瑞华夏医疗科技有限责任公司的<strong><span style="color: rgb(0, 153, 102);">中医</span></strong>经络检测仪</p><p>&nbsp;</p><p>　　规格型号为：ZR0301-JL</p><p>&nbsp;</p><p>　　受理号为：（京）[2015]38-8-01-191</p><p>&nbsp;</p><p>　　合同及临床试验报告等资料显示：北京宗古技术服务有限公司作为该公司的临床试验申办<strong><span style="color: rgb(0, 153, 102);">代理</span></strong>机构在中国人民解放军第二五一医院开展临床试验。但现场检查中，二五一医院否认其承接了该公司中医经络检测仪的临床试验项目。</p><p>&nbsp;</p><p>　　这个，连临床试验承接单位都是假的，造假造大发了！</p><p>&nbsp;</p><p>　　去年10月8日—10月21日，北京市药监局曾发布公告，要在该时间段内展开第一批<strong><span style="color: rgb(0, 153, 102);">医疗器械</span></strong>临床试验监督抽查工作，首批一共抽取了39个注册/备案项目，多为IVD产品。而此次公告被毙掉的6个注册申请项目，正包括在第一批抽查项目之中。</p><p>&nbsp;</p><p>　　北京市内药监局称，2017年，该局还将继续组织开展医疗器械临床试验监督抽查。</p><p>&nbsp;</p><p>　　去年，国家药监局和地方药监局纷纷启动医疗器械临床试验监督抽查工作。</p><p>&nbsp;</p><p>　　截止目前，国家局开展了2批监督抽查，共有8个医械注册申请项目，因为临床试验存在真实性问题被不予注册。</p><p>&nbsp;</p><p>　　地方局方面，除北京市之外，还有湖南省药监局揪出了4个IVD注册申请项目的临床试验问题，也给与其不予注册处理决定。</p><p>&nbsp;</p><p>　　至于其他更多省份的监督检查结果，则尚待出炉、公开。</p><p><br  /></p><p style="font-size: 16px; 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