Tentative Provisions for the Administration of the Designation of a Domestic Responsible Person by Foreign Marketing Authorization Holders

境外药品上市许可持有人指定境内责任人管理暂行规定

Foreign marketing authorization holders are required to designate a domestic responsible person in China / CLP Reference: 2600/24.11.13 ; Issued: 2024-11-13 ; Effective: 2025-07-01

By Susan Mok

(国家药品监督管理局于二零二四年十一月十三日发布，自二零二五年七月一日起施行。)

(Issued by the National Medical Products Administration on November 13, 2024 and effective as of July 1, 2025.)

国家药监局公告第137号

NMPA Announcement No.137

第一条为加强境外药品上市许可持有人的监督管理，落实药品上市后质量管理主体责任，规范境外药品上市许可持有人指定境内责任人活动，根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》及相关法律法规，制定本规定。

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