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Effective July 1, 2025, the National Medical Products Administration (NMPA) will enforce a new regulation titled the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders (MAHs). This landmark move aims to enhance regulatory oversight of imported pharmaceutical and medical products in China by requiring foreign MAHs to appoint a Designated Domestic Responsible Person (DDRP) within the country.

Why Has NMPA Introduced This Regulation?

The Interim Provisions are part of NMPA’s ongoing efforts to close regulatory gaps related to post-marketing responsibilities of foreign manufacturers. Historically, overseas MAHs could rely on local distributors without clearly defined regulatory obligations, especially in areas such as pharmacovigilance, recalls, and compliance audits.

This update seeks to:

  • Strengthen post-market surveillance
  • Ensure timely response to safety issues and product recalls
  • Improve communication and cooperation between NMPA and foreign MAHs
  • Promote accountability through a legally recognized in-country representative

What Is a Designated Domestic Responsible Person (DDRP)?

A Designated Domestic Responsible Person (DDRP) is a legal entity based in mainland China, authorized to act on behalf of a foreign MAH for all post-approval regulatory functions. The DDRP serves as the primary point of contact for NMPA and is accountable for product safety, regulatory filings, and inspection readiness.

Key Responsibilities of the DDRP

Under the new regulation, the DDRP must:

  • Monitor and report adverse drug reactions and other safety events
  • Coordinate product recalls and risk communication with authorities
  • Facilitate and support Regulatory audits and inspections
  • Ensure timely submission of Regulatory updates and compliance documentation

The DDRP effectively becomes the Regulatory “face” of the overseas MAH within China.

How Will This Regulation Impact Pharmaceutical Companies?

1. Mandatory Local Representation

Overseas MAHs will no longer be able to market their products in China without a registered domestic entity. Companies will need to either establish a local affiliate or contract with a third-party Regulatory agent or consulting firm capable of fulfilling DDRP responsibilities.

2. Increased Post-Market Compliance Requirements

The MAH will remain legally responsible for its products, but the DDRP will be held accountable for real-time safety monitoring, Regulatory reporting, and risk management. This calls for closer integration between global pharmacovigilance teams and local DDRPs.

3. Operational Adjustments and Legal Accountability

Companies must update their internal standard operating procedures (SOPs), assign appropriate authority to DDRPs, and formalize roles and responsibilities through legal agreements. Failing to meet compliance expectations may result in penalties, delayed product approvals, or product withdrawal.

4. Urgency to Prepare Before July 1, 2025

With the regulation taking effect mid-2025, pharmaceutical manufacturers must act now. Waiting until later in the year could result in operational bottlenecks, especially during the approval process for new or existing products.

What Should Companies Do to Prepare?

To ensure compliance and uninterrupted market access, pharmaceutical and medical device manufacturers should:

  • Conduct a readiness assessment to identify gaps in local regulatory representation
  • Select and onboard a qualified DDRP—either a subsidiary or trusted regulatory service provider
  • Review and revise internal documentation to reflect DDRP roles, responsibilities, and workflows
  • Establish robust data-sharing protocols between global MAH teams and the DDRP
  • Train key staff on China-specific Regulatory obligations and communication practices

Final Thoughts

China’s requirement for a Designated Domestic Responsible Person marks a significant shift in its post-market Regulatory strategy. By clearly defining who is responsible for local compliance, the NMPA is enhancing safety oversight and building a stronger, more transparent Regulatory environment.

Acting early and aligning with a reliable DDRP will be critical to ensuring a smooth transition and sustained success in China post-2025.

If you're an overseas MAH looking to navigate these new requirements, our Regulatory experts can support you with DDRP representation, local compliance strategy, and end-to-end Regulatory liaison services to ensure uninterrupted market access in China.