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

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

(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。)

NMPA Announcement No.137

国家药监局公告第137号

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