China’s National Medical Products Administration (NMPA) has announced the implementation of the 2025 edition of the “Pharmacopoeia of the People’s Republic of China” (hereinafter referred to as the “Chinese Pharmacopoeia”), which will take effect on October 1, 2025. This edition serves as a critical national drug standard, outlining compliance requirements for drug development, production, import, distribution, use, and supervision.

Key Policy Highlights

1. Legal Compliance
   • Mandatory Standards: All drugs must comply with the national drug standards as stipulated by the “Drug Administration Law,” with the Chinese Pharmacopoeia being a key component.
   • Scope: Applies to all entities involved in drug-related activities, including research, production, import, distribution, use, and supervision.
2. Content and Execution
   • Sections: Includes general rules, monographs, general technical requirements, and guidelines.
   • Effective Date: All listed drugs must adhere to the new standards from the implementation date.
3. Historical Standards
   • Replacement: Previous standards for varieties included in the new pharmacopoeia are废止.
   • Continuation: Varieties not included in the new edition must still meet general technical requirements of the new pharmacopoeia.
4. Registration Standards
   • Alignment: Drug marketing authorization holders must assess and align their registration standards with the new pharmacopoeia.
   • Changes: Any necessary changes to registration standards must be submitted before the implementation date.
5. Quality Control
   • Special Projects: For projects like dissolution and release, specific requirements may follow approved registration standards.
6. Name Revision
   • Updated Names: Drugs with revised generic names must use the new name, with the old name as a transitional alias.
7. Registration Applications
   • New Applications: Must comply with the new pharmacopoeia from the implementation date.
   • Pending Applications: Technical reviews for applications accepted before the implementation date must follow the new standards.
8. Transition Period
   • Post-Approval Compliance: Drugs approved between the publication and implementation dates must meet the new standards within six months.
9. Preparation and Feedback
   • Preparation: Stakeholders must prepare for implementation and report issues to the National Pharmacopoeia Commission.
   • Proactive Improvement: Continuous research and improvement of quality standards are encouraged.
10. Supervision and Guidance
    – Provincial Oversight: Provincial drug regulatory authorities must support implementation through supervision and guidance.
    – Technical Support: The National Pharmacopoeia Commission will provide training and technical guidance.

Policy Orientation and Industry Implications
The implementation of the 2025 edition of the Chinese Pharmacopoeia reflects China’s strategic focus on:

• Quality Enhancement: Elevating drug quality through stringent standards.
• Regulatory Precision: Refining regulatory requirements to ensure compliance across the industry.
• Industry Adaptability: Supporting enterprises in aligning with new standards to maintain market competitiveness.

Conclusion
China’s updated pharmacopoeia sets a higher benchmark for drug quality and safety, emphasizing compliance and continuous improvement. Stakeholders in the pharmaceutical sector should actively prepare for these changes to ensure smooth implementation and maintain high-quality standards.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20250325184202175.html