Key Update: New Interim Provisions on Designated Domestic Agents

The National Medical Products Administration (NMPA) has released the Interim Provisions on the Management of Designated Domestic Agents for Foreign Drug Marketing Authorization Holders. This important regulation aims to enhance the safety, quality, and post-marketing management of imported drugs in China.

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Implementation Timeline

· Effective Date: July 1, 2025
· A transition period allows foreign drug marketing authorization holders (MAHs) approximately 8 months to comply by designating domestic agents in line with the new requirements.

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What Does This Mean for Foreign MAHs?

Foreign MAHs must now appoint a designated domestic agent, who will act as their representative in China and share joint accountability for the drugs they bring to the market.
Responsibilities of Domestic Agents Include:
· Ensuring drug quality, safety, and post-marketing surveillance.
· Managing drug recalls and monitoring adverse reactions.
· Providing traceability information and ensuring compliance with regulatory requirements.
Domestic agents must also meet stringent criteria, including having:
· A registered corporate entity in China.
· A comprehensive quality management system.
· Adequate facilities and qualified personnel to oversee compliance.

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New Reporting and Transparency Measures

· System Support: Foreign MAHs can report their designated domestic agents via the newly launched National Drug Business Application System, operational since November 14, 2024.
· Public Disclosure: Information about designated domestic agents will be available on drug packaging and the NMPA's official website, ensuring transparency and public access.

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Why This Matters

The regulation reflects China’s commitment to strengthening its pharmaceutical regulatory framework and enhancing consumer protection. It ensures that foreign companies comply with stringent safety and quality standards, while also fostering transparency in the management of imported drugs.

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Next Steps for Stakeholders

1. Foreign MAHs: Review the Interim Provisions and initiate the process of designating a compliant domestic agent.
2. Domestic Agents: Prepare to meet the operational and legal requirements to support foreign MAHs in the Chinese market.
3. Healthcare Industry: Monitor updates on the NMPA’s website to stay informed on implementation guidelines and compliance resources.


Disclaimer:
This newsletter is for informational purposes only and does not constitute legal or regulatory advice. While we strive to provide accurate and up-to-date information, readers should consult the official documents published by the National Medical Products Administration (NMPA) or seek professional advice for specific compliance requirements. We are not responsible for any actions taken based on the information in this newsletter.