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The State Drug Administration of China has released an important update aimed at strengthening the quality management of pharmaceutical excipients and packaging materials. These updates, outlined in the recently issued Pharmaceutical Excipients Appendix and Pharmaceutical Packaging Materials Appendix, serve as supplementary provisions to the Good Manufacturing Practice for Pharmaceuticals (Revised in 2010). The changes are set to take effect on 1 January 2026 and focus on aligning industry practices with stringent quality standards while ensuring public health and safety.
Key Highlights of the New Regulations
1. Responsibilities for Manufacturers
Pharmaceutical excipients and packaging material manufacturers must:
Establish Robust Quality Management Systems
Companies are required to equip their operations with appropriate personnel and infrastructure to support consistent quality assurance. This includes maintaining detailed operational procedures and conducting regular quality assessments for raw material suppliers.
Adopt Rigorous Change Management
Any changes to production processes, raw material sources, or facilities must undergo risk assessment, research, and approval by quality management departments. These changes must be updated on the Centre for Drug Evaluation’s A/P registration platform.
Foster Collaboration with Drug Marketing Authorization Holders
Manufacturers are expected to facilitate audits, provide comprehensive documentation, and ensure transparent communication about quality control practices, complaints, or recalls.
2. Responsibilities for Drug Marketing Authorization Holders
Holders of drug marketing authorizations bear significant responsibility in ensuring the quality and safety of their products by:
Managing Supplier Quality
Authorization holders must sign quality agreements with suppliers, conduct regular audits, and evaluate the adherence of suppliers to the updated appendices.
Strengthening Quality Audits
A detailed audit of supplier quality management systems, including factory inspections, will help ensure compliance with risk-based manufacturing principles.
Overseeing Change Management:
Any modifications to pharmaceutical excipients or packaging materials must be closely monitored, with appropriate research, approval, and reporting to regulatory authorities as required.
3. Role of Regulatory Authorities
Provincial drug regulatory bodies are tasked with:
Conducting Supervision and Inspection
Authorities will supervise manufacturers through routine and risk-based inspections, ensuring adherence to the appendices. Non-compliant entities may face penalties, including adjustments to product registration status.
Promoting Compliance Before Implementation
Regulatory bodies will disseminate the new requirements and encourage manufacturers to enhance their quality management systems and facilities before the January 2026 deadline.
A Unified Approach to Quality Control
This announcement emphasizes the importance of collaboration between manufacturers, drug marketing authorization holders, and regulatory authorities. By adopting these updated practices, the pharmaceutical industry in China aims to bolster public trust in drug safety and efficacy while aligning with global best practices.
Preparing for 2026
Pharmaceutical excipients and packaging material manufacturers are encouraged to proactively meet the new standards before the implementation date. This includes upgrading facilities, refining quality systems, and fostering transparent communication channels with stakeholders.
Conclusion
The revised guidelines mark a significant step forward in ensuring the safety and quality of pharmaceuticals in China. By enforcing stringent quality controls and fostering industry-wide collaboration, these measures aim to safeguard public health and reinforce the integrity of the pharmaceutical supply chain.
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