《用于产生真实世界证据的真实世界数据指导原则（试行）》的通告（2021年第27号） 20210415
发布日期：20210415
为进一步指导和规范申办者利用真实世界数据生成真实世界证据支持药物研发，药审中心组织制定了《用于产生真实世界证据的真实世界数据指导原则（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。
国家药品监督管理局药品审评中心
2021年4月13日
附件 1 ：《用于产生真实世界证据的真实世界数据指导原则（试行）》.pdf
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