Tentative Provisions for the Administration of the Designation of a Domestic Responsible Person by Foreign Marketing Authorization Holders

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

NMPA Announcement No.137

Article 1:                These Provisions have been formulated pursuant to the PRC Law for the Administration of Pharmaceuticals, the PRC Law for the Administration of Vaccines and relevant laws and regulations in order to strengthen the oversight of foreign marketing authorization holders, implement entity liability for post-marketing quality management and regulate the activity of foreign1 marketing authorization holders designating Domestic2 Responsible Persons.

Article 2:                For the purposes of these Provisions, the term “Foreign Holder” means a foreign marketing authorization holder that has secured a pharmaceutical registration certificate issued by the National Medical Products Administration. A Foreign Holder shall be liable in accordance with the law for the safety, efficacy and quality control throughout the production of, dealing in and use of a pharmaceutical for which it holds a pharmaceutical registration certificate once the same is on the market.

For the purposes of these Provisions, the term “Domestic Responsible Person” means a domestic enterprise with legal personality designated by a Foreign Holder to perform the obligations of a marketing authorization holder in mainland China and bear joint and several liability with the marketing authorization holder.

Article 3:                These Provisions shall govern the designation of Domestic Responsible Persons by Foreign Holders in accordance with the law, the performance of the relevant obligations of a marketing authorization holder by Domestic Responsible Persons in mainland China as well as the activity of medical products administration overseeing Domestic Responsible Persons.

The National Medical Products Administration is charged with guiding the medical products administration of the provinces, autonomous regions and municipalities directly under the central government in overseeing Domestic Responsible Persons. The medical products administration of the provinces, autonomous regions and municipalities directly under the central government are responsible for the oversight of the Domestic Responsible Persons in their administrative regions.

Article 4:                A Domestic Responsible Person shall simultaneously satisfy the following conditions:

(1)               being an enterprise with legal personality established in mainland China;

(2)               having a quality management system commensurate with the task of performing the obligations of a marketing authorization holder;

(3)               having the appropriate personnel for performing the obligations of a marketing authorization holder and having dedicated personnel independently responsible for pharmaceutical quality management activities; and

(4)               having the appropriate office premises.

Article 5:                Before its pharmaceutical is first imported and sold, a Foreign Holder shall report its designated Domestic Responsible Person to the medical products administration of the province, autonomous regions or municipality directly under the central government where it is located via the National Pharmaceutical Business Application System and upload the materials authorizing its designated Domestic Responsible Person.

Article 6:                The authorization materials of a Domestic Responsible Person designated by a Foreign Holder shall include the following:

(1)               the name, contact telephone number and email address of the legal representative or authorized representative of the Foreign Holder and the name, contact telephone number and email address of its contact person;

(2)               the name and identity document information of the legal representative, enterprise person in charge and contact person of the Domestic Responsible Person, the enterprise’s correspondence address and its contact information, organizational chart, etc.;

(3)               the original of the obligation co-signing undertaking signed by the Foreign Holder or its authorized representative and the legal representative of the Domestic Responsible Person; and

(4)               a notarized list of the authorized responsibilities.

Materials bearing a reliable electronic signature or electronic seal that conforms with the provisions of laws shall have the same legal effect as those bearing a handwritten signature or seal.

Article 7:                With respect to any one pharmaceutical product marketed in mainland China, the Foreign Holder shall designate a sole Domestic Responsible Person therefor to perform the obligations of the marketing authorization holder. One Domestic Responsible Person may accept designations by different Foreign Holders and for different imported pharmaceutical products.

The name, address and contact information of the Domestic Responsible Person shall be provided in the directions for use of the pharmaceutical.

Article 8:                Where a Foreign Holder replaces its Domestic Responsible Person, the same shall be reported to the medical products administration of the post-change province, autonomous region or municipality directly under the central government where it is located via the National Pharmaceutical Business Application System within 15 working days after the entry into effect of the letter of authorization.

Where the particulars of a Domestic Responsible Person such as its corporate address or contact information changes, it shall report the same to the medical products administration of the province, autonomous region or municipality directly under the central government where it is located via the National Drug Business Application System in a timely manner.

A Foreign Holder shall report in its annual report changes in its Domestic Responsible Person during the previous year.

Article 9:                The National Medical Products Administration and the medical products administration of the provinces, autonomous regions and municipalities directly under the central government shall achieve the sharing of relevant information on the Domestic Responsible Persons in the administrative regions of the provinces via the National Regulatory Data Sharing Platform for Medical Products. The National Medical Products Administration shall file relevant information on Domestic Responsible Persons in pharmaceutical product files in a timely manner.

Article 10:            The National Medical Products Administration shall be responsible for disclosing relevant information on Domestic Responsible Persons, and the public shall have the right to review the same.

Article 11:            A Domestic Responsible Person and the Foreign Holder shall jointly perform the following obligations:

(1)               being responsible for the quality and safety of the pharmaceutical and establishing a post-marketing quality assurance system to ensure a continuing capacity to ensure quality and control risks;

(2)               being responsible for establishing and implementing a pharmaceutical traceability system to ensure that the relevant marketed pharmaceutical is traceable and providing traceability information in accordance with provisions;

(3)               being responsible for establishing and implementing a pharmaceutical annual report system and reporting information on the production and sale of the relevant pharmaceutical in mainland China, post-marketing research, risk management, etc. in accordance with provisions;

(4)               being responsible for establishing and implementing a system for managing post-marketing changes and re-registration of the pharmaceutical and carrying out the matters relating to changes in accordance with provisions;

(5)               being responsible for establishing a pharmacovigilance system and conducting monitoring, identification, assessment and control of adverse reactions to the marketed pharmaceutical and other harmful reactions relating to the use of the pharmaceutical;

(6)               being responsible for matters such as post-marketing recall of the pharmaceutical and handling of quality complaints, and reporting the same to the medical products administration of the province, autonomous region or municipality directly under the central government of the place where it is located in accordance with provisions;

(7)               submitting standard substances to the National Institutes for Food and Drug Control in accordance with provisions and actively cooperating in relevant work such as random inspections and releases arranged and carried out by the medical products administration;

(8)               being responsible for liaison with the Foreign Holder and cooperating with the medical products administration in its conduct of inspections and investigations of production premises relating to the Foreign Holder and investigation and handling of violations of laws and regulations thereby; and

(9)               other obligations as specified in laws and regulations.

Article 12:            A Foreign Holder shall be responsible for management of the authorization and replacement of its Domestic Responsible Person and ensure that its Domestic Responsible Person performs its obligations on an ongoing basis while the pharmaceutical is on the market.

Article 13:            When import record filing is carried out for the first time for an imported pharmaceutical, the port medical products administration shall verify whether the directions for use of the imported pharmaceutical provide the particulars of the Domestic Responsible Person.

Article 14:            The medical products administration of a province, autonomous region or municipality directly under the central government shall, in accordance with laws and regulations, conduct monitoring inspections of the pharmaceutical related activities engaged in by Domestic Responsible Persons performing the obligations of Foreign Holders in its administrative region. Relevant entities and individuals shall offer their cooperation, and may not refuse or dissemble.

The medical products administration of a province, autonomous region or municipality directly under the central government shall open regulatory files of Domestic Responsible Persons, the information therein to include information on monitoring inspections, investigations and the handling of violations of laws and regulations, handling of complaints and reports, etc.

Where the pharmaceutical registration certificate held by a Foreign Holder is canceled or revoked, the medical products administration of the province, autonomous region or municipality directly under the central government of the place where the Domestic Responsible Person for the pharmaceutical product is located shall be responsible for placing the relevant notation in the National Pharmaceutical Business Application System.

Article 15:            Where a Domestic Responsible Person fails to satisfy the conditions set forth in Article 4 hereof, the medical products administration of the province, autonomous region or municipality directly under the central government shall procure rectification thereof within the specified period of time. If the Domestic Responsible Person still fails to satisfy the relevant conditions after rectification, the medical products administration shall take measures such as suspension of sales or import.

Article 16:            Where a Domestic Responsible Person fails to perform an obligation set forth in Article 11 hereof, resulting in an imported pharmaceutical potentially posing a latent safety risk, the medical products administration of the province, autonomous region or municipality directly under the central government shall, in light of the outcome of a monitoring inspection, take measures such as giving a warning, calling in for a talk, ordering rectification within a specified period of time, or suspending sale, use or import, and announce the results of the inspection and handling in a timely manner.

Where a Domestic Responsible Person fails to perform a relevant obligation in accordance with the PRC Law on the Administration of Pharmaceuticals or the PRC Law on the Administration of Vaccines, it shall be penalized in accordance with relevant provisions of the PRC Law on the Administration of Pharmaceuticals or the PRC Law on the Administration of Vaccines.

Article 17:            The medical products administration of a province, autonomous region or municipality directly under the central government may formulate detailed implementing rules pursuant hereto.

Article 18:            These Provisions shall be effective as of July 1, 2025.

Translator’s notes: