药物临床试验数据递交指导原则(试行)

2020-07-20 国家药品监督管理局药品审评中心(CDE) CDE

为规范药品注册申请人递交药物临床试验数据及相关资料,配合新修订的药品注册申报资料要求,提高药品审评效率,药审中心组织制定了《药物临床试验数据递交指导原则(试行)》(见附件)。根据《国家药

中文标题:

药物临床试验数据递交指导原则(试行)

发布日期:

2020-07-20

简要介绍:

  为规范药品注册申请人递交药物临床试验数据及相关资料,配合新修订的药品注册申报资料要求,提高药品审评效率,药审中心组织制定了《药物临床试验数据递交指导原则(试行)》(见附件)。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》(药监综药管〔2020〕9号)要求,经国家药品监督管理局审核同意,现予发布。
       化学药品、生物制品自2020年10月1日起实施。中药实施日期按国家药监局发布中药注册分类及申报资料要求的通告中相关规定执行。
       特此通告。
                                                                                                                           国家药品监督管理局药品审评中心
                                                                                                                                         2020年7月20日

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#插入话题
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    2021-05-14 ms7000001395190706

    0

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    2021-05-14 ms7000001395190706

    嘻嘻

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    2020-08-05 ms4000001896071794

    你好呀朋友

    0