The National Medical Products Administration (NMPA) has released the “Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Drug Marketing Authorization Holders (MAHs)”. These provisions are designed to strengthen the management of overseas drug MAHs and to delineate the rights and responsibilities of these entities and their designated domestic responsible persons in China.
Regulations for Designated Responsible Persons
The document mandates that for each drug variety marketed in China, the overseas MAH must appoint a single responsible person within the country to fulfill the obligations of the drug marketing authorization holder. This designated person within China may accept appointments from different overseas MAHs and for different imported drug varieties, streamlining the management process.
Reporting and Authorization Process
Before the initial import and sale of drugs, overseas MAHs are required to report their designated domestic responsible person to the provincial medical products administration bureau where the designated person is located. This is to be done through the national drug business application system, along with uploading the authorization materials of the designated domestic responsible person. Should the overseas MAH decide to change the domestic responsible person, they must report this change to the relevant bureau through the same system within 15 working days after the new authorization letter takes effect.
Transition Period and Compliance Deadline
Overseas manufactured drugs that are already on the market for sale must ensure that a domestic responsible person is designated and that all relevant materials are reported and filed as required during the transition period. This period, which lasts approximately 8 months, allows overseas MAHs to select an eligible domestic responsible person. From July 1, 2025, all overseas manufactured drugs that are produced or released must comply with the requirements of the Interim Provisions, with information on the responsible person within the country included in the instructions.-Fineline Info & Tech
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