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【征求意见】国家药监局核查中心公开征求《抗体偶联药物生产质量管理指南（征求意见稿）》意见

发布时间：2026-10-30 00:00:00

作者：国家药监局

阅读次数：171

【征求意见】国家药监局核查中心公开征求

《抗体偶联药物生产质量管理指南（征求意见稿）》意见

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为指导和规范抗体偶联药物生产企业的生产质量管理活动，供药品监督管理部门开展相关现场检查参考，国家药监局核查中心组织起草了《抗体偶联药物生产质量管理指南（征求意见稿）》,

现面向社会公开征求意见，截止日期为2026年11月20日前。

本指南主要聚焦于有效载荷为小分子细胞毒性药物的ADC产品，对该类 ADC产品的生产质量管理要求进行阐述。其他偶联药物如多肽偶联药物、抗体寡核苷酸偶联药物等也可参考本指南。

本指南适用于我国境内拟上市和已上市的ADC生产企业的生产质量管理活 动与监管部门开展的现场检查工作，覆盖ADC产品全生命周期中与质量直接相关的环节，包括但不限于：抗体的生产，连接子、有效载荷、有效载荷-连接子的合成制备，ADC原液制备，ADC制剂生产，成品包装及与之相配套的全链条质量控制活动。




附件：1.抗体偶联药物生产质量管理指南（征求意见）.pdf

          2.意见反馈表.docx.pdf

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