China Finalizes Long-Awaited Drug Domestic Responsible Person (Domestic Agent) Rule

On November 14, 2024, China's National Medical Products Administration ("NMPA") issued the Interim Provisions on the Administration of the Designation of Domestic Responsible Person by Overseas Drug Marketing Authorization Holders (the "Interim Provisions"). The Interim Provisions, which were issued after four years of discussion, lay out the appointment procedures and the required qualifications and obligations of the "domestic responsible person" for overseas drug marketing authorization holders ("MAHs") for each individual "drug variety." The Interim Provisions will come into effect on July 1, 2025, leaving an eight-month grace period for overseas MAHs to come into compliance.

The Interim Provisions define the "domestic responsible person" as a domestic legal person (i.e., an entity) designated by the overseas MAH to perform the MAH's obligations within the territory of Mainland China and bear joint liability with the overseas MAH. The Interim Provisions provide that there can be only one responsible person per "drug variety," which is an undefined term in the Interim Provisions, but could be read to include all indications approved for a particular registered drug product. A particular domestic responsible person is not limited to one drug or one overseas MAH. Presumably, companies could designate different entities to serve as the domestic responsible person for different drugs under the Interim Provisions.

The domestic responsible person must have personnel, office space, and a quality management system suitable for fulfilling the MAH's obligations. The domestic responsible person and the overseas MAH will jointly perform drug quality management obligations, including ensuring traceability, filing annual reports, managing post-marketing changes, and performing pharmacovigilance obligations, such as adverse drug reaction reporting and recalls.

Before the first importation and sale of its drug in China, the overseas MAH must designate a domestic responsible person with the applicable provincial-level locality by filing relevant information through the National Medical Products Business Application System (the "System"). This filing includes basic information on the overseas MAH and the domestic responsible person, a co-signed commitment letter on the obligations of both parties, and a notarized list of obligations that the domestic responsible person will perform. If the overseas MAH changes its domestic responsible person, it must report the change through the System within 15 working days after the change takes effect. The overseas MAH must list the domestic responsible person's information (name, address, contact information) in the drug package insert, as well as incorporate the domestic responsible person and its role in its overseas quality system.

The full text of the Interim Provisions is available here: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20241114172951120.html.

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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John Balzano, Julia Post, Muyun Hu, Kaixin Fan, and Kexin Yang.