医疗器械注册使用境外临床试验数据的基本原则

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　　为了避免或减少申请人通过医疗器械境外临床试验数据申报注册过程中重复性临床试验，加快医疗器械在我国上市进程，国家食品药品监督管理总局组织制定了接受医疗器械境外临床试验数据技术指导原则。其中涉及的境外临床试验数据是指，全部或同期在境外具备临床试验开展所在国家（地区）要求条件的临床试验机构中，对拟在我国申报注册的医疗器械在正常使用条件下的安全有效性进行确认的过程中所产生的研究数据，需要符合下列基本原则。

　　一、伦理原则

　　境外临床试验应当遵循《世界医学大会赫尔辛基宣言》确定的伦理准则。申请人同时需说明采用的临床试验开展所在国家（地区）的伦理、法律、法规所制定的规范和标准，或国际规范和标准。

　　二、依法原则

　　境外临床试验应当在有临床试验质量管理的国家（地区）开展，并且符合我国医疗器械（含体外诊断试剂）临床试验监管要求，若临床试验所符合的临床试验质量管理文件与《医疗器械临床试验质量管理规范》（GCP）有差异，应详细说明差异内容，并充分证明差异内容不影响研究结果的真实性、科学性、可靠性及可追溯性，且能够保障受试者权益。申请人及临床试验机构应接受国家食品药品监督管理总局的监督检查。

　　三、科学原则

　　境外临床试验数据应真实、科学、可靠、可追溯，申请人应提供完整的试验数据，不得筛选。而且申请人应确保在境外开展的临床试验目的适当，试验设计科学合理，试验结论清晰，受试者的权益得到保障，其他人员可能遭受的风险得以保护。

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smlqf3 发表于 2018-9-8 00:52
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