China’s Pharmaceutical Packaging Standards: An Overview of the 2025 Chinese Pharmacopoeia Framework and Compliance Strategies

22 Dec 2025

With the publication of the 2025 edition of the Chinese Pharmacopoeia (“2025 ChP”), China’s regulatory framework for pharmaceutical packaging is entering a new phase of modernization, marked by scientific rigor, lifecycle management, and stronger alignment with international practices. For both domestic and global pharmaceutical companies, understanding the structure and implications of the 2025 ChP is essential for navigating regulatory requirements, ensuring market access, and protecting the safety of consumers.

The 2025 ChP Framework

The 2025 ChP introduces a new framework for pharmaceutical packaging standards: the “1+4+58” framework. This system replaces the previous fragmented approach with a more integrated, science-based model. The “1+4+58” framework is broken down into the following:

• “1”: The Overarching Guiding Principle
  The framework is governed by 1 overarching guiding principle: 9621 – Guiding Principle for General Requirements for Pharmaceutical Packaging Materials. This is the foundational standard that defines pharmaceutical packaging as an essential part of the drug product. It introduces a lifecycle-driven risk management framework and outlines core quality expectations through the “four properties and one stability” concept: protection, compatibility, safety, functionality, and intrinsic stability. These attributes form the scientific basis for evaluating packaging suitability across the full lifecycle of a drug.
  
  
• “4”: The Material-Specific Standards
  Supporting the guiding principle are 4 material-focused guidelines. These guidelines include revised requirements for glass containers (9622 -Guiding Principle for Glass Materials and Containers) and newly introduced standards for rubber sealing components (9623 -Guiding Principle for Rubber Sealing Parts), plastic packaging (9624 -Guiding Principle for Plastic Materials and Containers), and metal containers (9625 -Guiding Principle for Metal Materials and Containers). Each document provides detailed information on the classification, manufacturing requirements, performance criteria, and quality controls applicable to each material type based on its characteristics. This structured approach outlines the regulatory expectations across packaging formats while recognizing the technical complexity of different substrates.
  
  
• “58”: The Universal Testing Methods
  The final piece of the framework is a suite of 58 universal testing methods that form the technical backbone for evaluating pharmaceutical packaging. The 2025 ChP includes 42 new methods and 16 updated methods, creating a comprehensive approach that covers chemical, physical, and functional performance testing. This expanded set of testing methods reflects China’s move toward enhanced scientific rigor, harmonized quality expectations, and improved regulatory consistency.

Compliance Pathway

To achieve compliance with the 2025 ChP, pharmaceutical companies must first integrate internal assessments and risk-based quality evaluations into their compliance efforts. Manufacturers must identify critical quality attributes for their packaging materials and ensure alignment with the 2025 ChP in order to establish the foundation for the subsequent validation and regulatory steps.

Once internal assessments are complete, manufacturers must generate scientific evidence supporting the “four properties and one stability” concept. This involves conducting a full suite of tests drawn from the 58 standardized methods, covering aspects such as material identity, mechanical performance, barrier properties, as well as safety evaluations that include extractables and leachables studies. The resulting data must demonstrate that the packaging materials can safely and effectively protect the drug product under the expected conditions of use.

The final step in the compliance pathway is preparing a Declaration of Conformity. This document summarizes compliance with relevant regulations and standards, outlines quality control measures, and presents the test data and technical justifications needed to support regulatory acceptance. It serves as a comprehensive record of a manufacturer’s commitment to quality and compliance.

Preparing for a New Era of Packaging Compliance

The introduction of the “1+4+58” structure represents a major milestone in China’s pharmaceutical regulatory evolution. By integrating risk-based principles with robust technical standards, the 2025 ChP elevates the quality and safety expectations for packaging throughout the pharmaceutical supply chain.

For manufacturers seeking to navigate these changes, proactive preparation and strong technical support are essential.

Intertek Is Here to Help!

Intertek China offers extensive laboratory services that align directly with the requirements of the 2025 ChP, covering various types of pharmaceutical packaging materials including composite films, plastic bottles, glass containers, co-extruded bags, rubber stoppers, pre-filled syringes, pen injectors, combination caps, and multilayer or composite systems. Our testing services include:

• Material identification using techniques such as Fourier transform infrared spectroscopy (FTIR), density measurements, and differential scanning calorimetry (DSC);
• Chemical analyses, including leaching studies and resistance testing;
• Barrier and sealing performance evaluations;
• Physical and mechanical performance testing; and
• Impurity and component analysis, such as metal content and residual monomers.

In addition to laboratory services, Intertek China provides consulting services to help manufacturers interpret the 2025 ChP standards, identify compliance gaps, evaluate risks, and design compliance roadmaps. These advisory services enable companies to align their internal systems with regulatory expectations and prepare complete, accurate Declarations of Conformity.

Intertek China helps manufacturers validate all critical attributes required under the 2025 ChP’s updated risk-based approach. Through our combination of advanced testing capabilities and expert regulatory guidance, we are well-positioned to ensure companies meet compliance requirements with confidence while enhancing product quality and protecting consumer safety as China’s pharmaceutical market continues to expand.