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陕西省医疗器械质量监督检验院 >> 信息动态 >> 政策法规 >> 正文 365bet官方博客_365bet线上棋牌_365bet体育开户网址
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陕西省医疗器械质量监督检验院 >>365bet体育开户网址 >> 正文
食品药品监管总局、国家卫生计生委联合发布《医疗器械临床试验质量管理规范》
作者: 信息来源:转载自国家局网站 点击数:1817 更新时间:2016/3/25 4:23:25

  365bet体育开户网址为进一步加强医疗器械临床试验监督管理,近日,国家食品药品监督管理总局、国家卫生和计划生育委员会联合发布《医疗器械临床试验质量管理规范》(食品药品监管总局令第25号)。《规范》共11章96条,包括总则、临床试验前准备、受试者权益保障、临床试验方案、伦理委员会职责、申办者职责、临床试验机构和研究者职责、记录与报告、试验用医疗器械管理、基本文件管理、附则。《规范》将于2016年6月1日起施行。 ?

  通过临床试验获得有效数据是评价医疗器械是否安全有效的重要方式之一。《规范》根据我国实际情况,参照国际相关标准、借鉴国外先进的管理经验,从保护受试者权益出发,重点在以下几个方面,规范医疗器械临床试验行为,保证临床试验结果的真实、可靠、准确、科学和完整: ?

  一是明确临床试验申办者、临床试验机构和研究者以及临床试验的监管部门等各方职责,强调申办者对临床试验的管理责任、细化临床试验机构和研究者的责任和义务要求。

  二是加强对受试者权益的保护,完善相关管理制度和要求,突出伦理委员会的作用和受试者知情同意,明确要求申办者对发生与试验相关的伤害或者死亡的受试者承担治疗的费用及相应的经济补偿。 ?

  三是严格临床试验风险管理,强调临床试验全过程的风险控制,明确临床试验的暂停和终止机制,落实申办者的主体责任,保证临床试验过程的安全和可控。

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