NMPA Announcement on Issuing the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders

(No. 137, 2024)

To implement the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China, and to strengthen the management of overseas marketing authorization holders (MAHs), the National Medical Products Administration (NMPA) has formulated the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders. These provisions are hereby issued and will come into effect from July 1, 2025.

Additionally, to ensure the effective implementation of the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders, the NMPA has developed relevant modules in the National Pharmaceutical Business Application System, which will be officially launched on November 14, 2024.

It is hereby announced.

National Medical Products Administration

November 13, 2024