China’s NMPA issues more detailed requirements for overseas drug MAHs and their domestic responsible persons

On 13 November 2024, the National Medical Products Administration (NMPA) formally promulgated the Interim Provisions on the Administration of the Designation of Domestic Responsible Persons by Overseas Drug Marketing Authorisation Holders. These Interim Provisions further clarify the requirements and related obligations for overseas drug Marketing Authorisation Holders (MAHs) when selecting their domestic responsible persons (DRPs).

In recent years, China has strengthened regulatory supervision in the life sciences sector. A key part of China's regulatory framework, the DRP system ensures the quality and safety of imported pharmaceutical products. Previously, the NMPA published a draft Medical Device Administration Law on 28 August 2024 for public comments, which emphasised the DRP system. (An analysis of this draft can be found here.) The newly introduced Interim Provisions elaborate on the qualification requirements and obligations of DRPs designated by MAHs in line with the Drug Administration Law.

Key points of the Interim Provisions

• Qualification requirements for DRP – The Interim Provisions stipulate that a DRP must meet the following requirements:
• Legal entity in China: The DRP must be an enterprise established within China.
• Quality management system: The DRP must operate a quality management system able to fulfil the obligations of an MAH.
• Personnel and infrastructure: The DRP must have appropriate personnel and institutional capabilities to fulfil the MAH's obligations, including staff independently responsible for drug quality management.
• Suitable office: The DRP must maintain a suitable office.

Each imported drug must have a single designated DRP. A single DRP can represent multiple MAHs and products.

Joint liability of DRPs and overseas MAHs

The Drug Administration Law stipulates that DRPs and overseas MAHs are jointly and severally liable for the quality and safety of imported drugs. The Interim Provisions outline these joint obligations, which include but are not limited to:

• Reporting production, sales, post-market research, and risk-management activities to the relevant authorities.
• Submitting annual reports to regulatory authorities detailing the production, sales, post-marketing research, and risk management of drugs in China.
• Managing post-market recalls and addressing quality complaints with mandatory reporting to authorities.

Reporting and disclosure requirements

The Interim Provisions state that the MAH must report DRP information to the competent provincial MPA via the official system. This must include the notarised authorisation documents and Letter of Commitment.

In addition, DRP details must be clearly stated in the drug’s instruction manual. The NMPA will also make this information publicly available online for transparency.

While DRP designation does not require administrative approval or affect drug registration, non-compliance may result in rectification orders, sales suspensions, or import bans.

Grace period

The Interim Provisions will take effect on 1 July 2025. Overseas MAHs with drug products on the Chinese market must:

• Ensure that the designated DRP complies with the Interim Provisions prior to the implementation date.
• Update instruction manuals to include DRP information.
• Submit necessary reports and documents.

Conclusion

The issuance of the Interim Provisions addresses the previously vague responsibilities of DRPs, strengthens qualification requirements, and provides clearer compliance guidelines for foreign pharmaceutical companies. Overseas MAHs are strongly encouraged to prepare in advance to meet these new regulatory obligations.

The original publication can be found here (Chinese only).

For more information on the Interim Provisions, contact your CMS client partner or these CMS experts.