基因治疗产品长期随访临床研究技术指导原则(试行)

2021-12-03 国家药品监督管理局药品审评中心(CDE) CDE

为指导和规范基因治疗类药物临床试验,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《基因治疗产品长期随访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

中文标题:

基因治疗产品长期随访临床研究技术指导原则(试行)

发布日期:

2021-12-03

简要介绍:

为指导和规范基因治疗类药物临床试验,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《基因治疗产品长期随访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。

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    2021-12-10 微探

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    2021-12-09 微探

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