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To enforce the Drug Administration Law of the People’s Republic of China and the Vaccine Administration Law of the People’s Republic of China while enhancing oversight of overseas drug marketing authorization holders, the National Medical Products Administration (NMPA) has issued the Interim Provisions on the Management of Domestic Responsible Persons designated by Overseas Drug Marketing Authorization Holders (ODMAHs). These provisions will take effect on 1 July 2025 and provide an eight-month transition period for ODMAHs to comply. This ensures sufficient time to establish partnerships with qualified DRPs and adapt to the new system.
NMPA launched updated National Drug Business Application System modules on 14 November 2024, to ensure seamless implementation.
Key Features of the Regulation
1. Domestic Responsible Persons (DRPs) Qualification Requirements
Corporate entity established in China
Possess a robust quality management system aligned with the obligations of a drug marketing authorization holder
Have personnel and facilities dedicated to ensuring drug quality
2. Domestic Responsible Persons (DRPs) Obligations
DRPs are jointly responsible with the ODMAHs for:
Drug quality and safety, including post-marketing quality assurance and risk control
Establishing a traceability system for drugs, ensuring accountability in cases of recalls or complaints
Implementing pharmacovigilance to monitor adverse reactions and submitting regular reports on drug safety
3. Reporting and Transparency
Before marketing any drug in China, DMAHs must:
Register the designated DRPs with the provincial drug regulatory authority through the NMPA’s business application system
Update any changes in DRPs designation within 15 working days
4. Enforcement and Penalties
Non-compliance with DRPs obligations could result in penalties, including suspension of drug sales and imports and additional corrective actions.
Implications for the Pharmaceutical Industry
These changes highlight China’s commitment to aligning with international standards while prioritizing domestic consumer safety. Pharmaceutical companies aiming to operate in China must recognize the critical role of DRPs and proactively adjust their strategies to meet the stringent requirements. As the implementation date approaches, stakeholders should engage with legal and regulatory experts to ensure seamless adaptation to this landmark policy.
The Interim Provisions underscore a broader trend of regulatory modernization in China, setting a precedent for collaboration between international pharmaceutical players and domestic regulatory authorities.
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