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Quality is the lifeline of enterprise and the safeguard of drug safety.
At the beginning of 2025, China’s National Medical Products Administration (NMPA) released the “Annex for Pharmaceutical Packaging Materials” under the Good Manufacturing Practice for Drugs (2010 Revision). This new regulation is set to be officially implemented on January 1, 2026, marking a new phase in the supervision of pharmaceutical packaging materials in China.
Simultaneously, the Chinese Pharmacopoeia (2025 Edition) has also established a comprehensive “1+4+58” standard system for pharmaceutical packaging materials, including 1 general requirement guiding principle, 4 material-specific guiding principles, and 58 general testing methods.
For us, specializing in the production of pharmaceutical spray packaging such as nasal sprays, throat sprays, and topical sprays, these new regulations represent not just compliance requirements but a significant opportunity to drive industrial upgrading and enhance product quality.
Core Changes in the New Regulations: From “Having Standards to Follow” to “High-Quality Standards”
The 2025 regulatory system for pharmaceutical packaging materials introduces several major changes that directly impact the production and control of pharmaceutical spray packaging:
- Shift in Regulatory Model: Transition from the original YBB standard system to a standard framework led by the Chinese Pharmacopoeia. After the promulgation of the Chinese Pharmacopoeia (2025 Edition), the corresponding methods in the original standards will be superseded by the new version.
- Upgraded Quality Control: The new regulations set comprehensive requirements for the protection, compatibility, safety, functionality, and intrinsic stability of pharmaceutical packaging materials, with particular emphasis on enhancing standards for barrier properties. For instance, the scope of the gas transmission measurement method has been expanded, the concept of gas transmission rate has been added, and terminology abbreviations have been harmonized.
- Standardized Production Management: The Annex for Pharmaceutical Packaging Materials sets detailed requirements for the entire production process, covering material management, production processes, quality control, change management, and other aspects, providing enterprises with a clearer framework for quality management.
Our Factory’s Active Response: From Passive Compliance to Proactive Upgrading
In response to the new requirements, our factory is actively taking steps to comprehensively enhance management levels and technical capabilities:
Comprehensive Upgrade of the Quality Management System
- We have rebuilt our quality management system in accordance with the new regulations, deploying personnel and organizational structures commensurate with our production scale, and establishing detailed management documents and operating procedures.
- We have particularly strengthened the management system for production molds, implementing a numbering system for each set of molds to ensure full lifecycle traceability.
- We have improved our change management system to ensure that any changes potentially affecting the quality of pharmaceutical packaging materials are fully studied, effectively controlled, and promptly communicated to the Marketing Authorization Holders (MAHs) of the drugs.
Enhanced Testing Capabilities and Process Control
- In response to the new requirements for the barrier properties of pharmaceutical packaging materials, we have introduced advanced gas transmission measurement instruments to ensure that key indicators such as product oxygen transmission rate comply with the new regulations.
- We have strengthened parameter control during the production process, establishing comprehensive batch production records to ensure that each batch of products can be traced back to its raw material sources and production history.
- We strictly implement sample retention management regulations, providing reliable support for the investigation and analysis of any product quality issues.
Optimized Customer Collaboration and Technical Support
- We proactively communicate with Marketing Authorization Holders (MAHs), sharing quality information and change notifications, ensuring that customers are kept informed about the compliance status of our products.
- We provide comprehensive technical documentation support to assist customers in completing the filing and reporting procedures for changes in pharmaceutical packaging material suppliers.
- We conduct joint quality assessments with key clients to ensure that our spray heads and bottle products are compatible with drug formulations and processes, meeting regulatory requirements.
Conclusion
The implementation of the 2025 regulations for pharmaceutical packaging materials will effectively drive industry consolidation and accelerate the phasing out of backward production capacities, promoting a shift from fragmented competition towards concentration and intensification in the sector.
For us, the new regulations present not only challenges but also a crucial opportunity to enhance our competitiveness and gain greater market recognition.
We are committed to responding with the most proactive attitude and the most solid work ethic to ensure our factory fully complies with the new requirements. We will provide our customers with safer, higher quality, and more stable pharmaceutical spray packaging products, working together to safeguard public medication safety.
Embrace change to lead the future!