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人用狂犬病疫苗临床研究技术指导原则(试行)

2022-03-18 国家药品监督管理局药品审评中心(CDE) CDE

为指导和规范人用狂犬病疫苗临床试验,提供可参考的技术规范,在国家药品监督管理局的部署下,药审中心组织制定了《人用狂犬病疫苗临床研究技术指导原则(试行)》(见附件)。根据《国家药监局综合司关

中文标题:

人用狂犬病疫苗临床研究技术指导原则(试行)

发布日期:

2022-03-18

简要介绍:

 为指导和规范人用狂犬病疫苗临床试验,提供可参考的技术规范,在国家药品监督管理局的部署下,药审中心组织制定了《人用狂犬病疫苗临床研究技术指导原则(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查同意,现予发布,自发布之日起施行。

       特此通告。

       附件:人用狂犬病疫苗临床研究技术指导原则(试行)

                                                                                                                                                                        国家药监局药审中心

                                                                                                                                                                            2022年2月18日

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