On November 14, 2024, China's National Medical Products Administration (NMPA) issued the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders (MAH) of Drugs (hereinafter referred to as the Provisions). The Provisions establish a comprehensive framework for the qualifications and requirements of domestic responsible persons designated by overseas drug MAHs and provide clear guidelines for reporting information about domestic responsible persons.
Conditions and Requirements for Domestic Responsible Persons
Pursuant to the Provisions, domestic responsible persons must satisfy the following criteria:
Legal Entity: Be an enterprise legal entity established within the territory of China.
Quality Management System: Maintain a quality management system that is commensurate with the obligations of the MAH.
Personnel and Organizational Structure: Possess the institutional capacity and qualified personnel necessary to fulfill the MAH's obligations, including dedicated staff independently responsible for drug quality management activities.
Office Facilities: Have appropriate office premises to support their operations.
In cases where a domestic responsible person fails to meet these requirements, the provincial-level drug regulatory authorities shall mandate corrective actions within a specified timeframe. If compliance is not achieved, following rectification and regulatory measures, such as suspending the sale or importation of the affected overseas-manufactured drugs, will be enforced.
Furthermore, the Provisions clarify that for any drug product marketed in China, the overseas MAH must designate a single domestic responsible person to assume the MAH's responsibilities for that drug. However, a domestic responsible person may be designated by multiple overseas MAHs or for various imported drug products.
Requirements for Reporting Information of Domestic Responsible Persons
Before the first importation of a drug product, the overseas MAH must report its designated domestic responsible person to the provincial-level medical product administration in the location of the domestic responsible person through the Domestic Responsible Person Information Reporting System. The system was launched on the day the Provisions were issued. MAHs can register or log in via the website (https://zwfw.nmpa.gov.cn/) to submit the required information of their designated domestic responsible persons.
In cases where the overseas MAH changes its designated domestic responsible person, the MAH must notify the provincial-level medical product administration in the location of the new domestic responsible person within 15 working days after the new authorization letter takes effect.
Implementation Timeline
The Provisions regulate an 8-month transition period, allowing overseas MAHs of existing marketed drugs to select compliant domestic responsible persons, prepare necessary reporting documentation, and update drug package inserts in accordance with the new Provisions.
Effective July 1, 2025, all overseas-manufactured drugs must adhere to the Provisions, including the inclusion of the domestic responsible person's name, address, and contact details on the drug package insert.
