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关于2018年第二批医疗器械临床试验监督抽查情况的公告(2019年第38号)

时间:2019-05-07       作者:检验视界网      浏览量:2912 次

 为贯彻实施《医疗器械监督管理条例》,落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42号),加强医疗器械临床试验监督管理,国家药品监督管理局于2018年12月组织开展了2018年第二批医疗器械注册申请项目临床试验监督抽查工作。现将检查结果、处理决定和有关要求公告如下:

一、检查结果
 ?。ㄒ唬┐嬖谡媸敌晕侍獾那榭?/span>


  1.北京宏强富瑞技术有限公司的中红外1550激光点阵治疗仪(受理号:CQZ1700097)在中国人民解放军第二五四医院开展的临床试验中,未按医疗器械注册申报提交的临床试验方案中随机对照要求开展试验。注册申请提交的临床试验资料与临床试验机构保存的试验资料不一致。


  2.江苏华夏医疗器械有限公司的一次性使用疼痛治疗包(受理号:CQZ1700482)在郑州大学第二附属医院开展的临床试验中,17例受试者入组时间由早于伦理委员会批准时间改为晚于伦理委员会批准时间,临床试验数据无法溯源。


 ?。ǘ┐嬖谖シ雌渌俅彩匝橛泄毓娑ǖ那榭?.江苏华夏医疗器械有限公司的一次性使用疼痛治疗包(受理号:CQZ1700482)在郑州大学第二附属医院开展临床试验期间,郑州大学第二附属医院无医疗器械临床试验机构资质。


  2. 冠昊生物科技股份有限公司的生物骨修复材料(受理号:CQZ1700591)在河南省洛阳正骨医院和长沙市第三医院开展的临床试验中,两家临床试验机构伦理委员会批准时间及首例病例筛选时间早于医疗器械注册检验报告的部分检测项目时间。


 ?。ㄈ┐嬖诤瞎嫘晕侍獾那榭?/span>


  此次核查发现的合规性问题主要表现在:未提供《医疗器械临床试验备案表》;知情同意书签署不规范;未按临床试验方案规定做筛选检查;主要疗效指标随访超过临床试验方案规定的时间窗;漏记不良事件和严重不良事件;受试产品的运输、交接和储存记录不完整等。


  二、处理决定


 ?。ㄒ唬┍本┖昵扛蝗鸺际跤邢薰镜闹泻焱?550激光点阵治疗仪(受理号:CQZ1700097)和江苏华夏医疗器械有限公司的一次性使用疼痛治疗包(受理号:CQZ1700482)两个注册申请项目的临床试验违反《医疗器械临床试验质量管理规范》,根据《中华人民共和国行政许可法》第七十八条和《医疗器械注册管理办法》第三十九条规定,对上述两个注册申请项目作出不予注册的决定,并自不予注册之日起一年内不予再次受理。责成北京市药品监督管理局和江苏省药品监督管理局分别对两家企业按照相关规定处理,并向国家药品监督管理局报告处理结果。
 ?。ǘ┰鸪珊幽鲜∫┢芳喽焦芾砭侄灾V荽笱У诙绞粢皆喊凑障喙毓娑ù?,函告相关卫生行政管理部门并向国家药品监督管理局报告处理结果。将中国人民解放军第二五四医院开展的医疗器械临床试验存在的问题函告中央军委后勤保障部卫生局。


 ?。ㄈ┕陉簧锟萍脊煞萦邢薰镜纳锕切薷床牧希ㄊ芾砗牛篊QZ1700591)注册申请项目的临床试验违反《医疗器械临床试验质量管理规范》,根据《医疗器械注册管理办法》第三十九条规定,作出不予注册的决定。


 ?。ㄋ模┒杂诖嬖诤瞎嫘晕侍獾淖⒉嵘昵胂钅?,国家药品监督管理局将结合注册申报资料和临床试验监督检查情况进行综合分析,按照相关规定开展审评审批。


  三、有关要求


 ?。ㄒ唬└魇∫┢芳喽焦芾砭忠叨戎厥右搅破餍盗俅彩匝榧喽焦芾砉ぷ?,采取有效措施,加强对本辖区内临床试验机构和申办者的监管,切实落实药品安全“四个最严”的要求。


 ?。ǘ┮搅破餍盗俅彩匝樯臧煺?、临床试验机构和伦理委员会要对存在的问题进行积极整改,严格执行《医疗器械临床试验质量管理规范》等相关要求,保证临床试验过程科学规范、结果真实可靠,切实保障受试者的合法权益。

特此公告。

                                                                                                                                                                                                国家药监局

                                                                                                                                                                                          2019年4月30日






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