China CDE Draft Guidance on Pharmaceutical Packaging Specifications

China's Center for Drug Evaluation (CDE) released a draft guidance titled Guidelines for Developing Appropriate Pharmaceutical Packaging Specifications on August 5, 2025. This initiative reflects China’s ongoing efforts to optimize pharmaceutical packaging specifications, reduce waste, and enhance clinical efficiency, aligned with the 2023 Action Plan for Saving Medical Resources jointly issued by five national agencies. The document was open for public consultation until September 5, 2025.

Policy Background

The draft addresses two long-standing challenges in China’s pharmaceutical packaging landscape:

Excessive packaging for certain drug products, leading to resource inefficiencies.
Insufficient availability of large-pack formats, particularly for inpatient use, which increases operational burdens on healthcare institutions.

The guidance aims to standardize packaging specifications across product types and usage scenarios, ensuring that packaging design supports clinical functionality, patient convenience, and economic sustainability.

Scope of Application

The guidance applies to:

Chemical drugs, biologics, traditional Chinese medicines
Primary, secondary, and large packaging

A key focus is the differentiation of packaging specifications based on the intended use setting – outpatient vs. inpatient. The document encourages applicants to incorporate packaging design considerations during the early stages of product development, ensuring alignment with clinical needs and regulatory expectations.

Core Design Principles

The document outlines three key dimensions that should guide packaging specification decisions:

Dimension Outpatient Drugs Inpatient Drugs Functional Requirements Smaller packaging for short-term use; tailored to acute conditions Larger packaging for long-term or bulk use; tailored to chronic conditions Convenience Reduce unnecessary visits; packaging aligned with disease characteristics Simplify clinical use; reduce unpacking time for medical staff Economic Considerations Simple, practical packaging to minimize waste and support patient use Economical packaging that supports operational efficiency and environmental goals

Implications for Pharmaceutical Companies

Early Development Integration:

Packaging specifications should be incorporated during initial product design, not deferred until post-approval. This shift requires closer alignment between CMC, regulatory, and commercial functions.

Post-Approval Changes:

For marketed products, packaging changes must follow the Post-Approval Change Regulations. Companies must:

Classify changes as minor, moderate, or major.
Prepare supporting data, including stability and compatibility studies.

GMP and Quality System:

Multiple packaging formats introduce complexity in quality control and supply chain management. Companies should:

Strengthen GMP-compliant change control procedures.
Ensure traceability and consistency across packaging variants.
Consider environmentally sustainable materials and design efficiencies.

Further Information

On August 5, 2025, the China Center for Drug Evaluation (CDE) released a draft of the Guidelines for Developing Appropriate Pharmaceutical Packaging Specifications, outlining expectations for material compatibility, stability data, and documentation.

👉 Click here to read the original announcement.

If you have questions about how these draft guidelines may affect your packaging specifications, GMP documentation, or product registration strategy in China, we encourage you to reach out to us.

For further insights, these recent articles could be of interest:

GMP for Excipients and Packaging - Draft for Comments
Explains the draft GMP guidelines for pharmaceutical excipients and packaging materials issued by the NMPA, which aim to standardize quality management systems and will significantly impact packaging compliance requirements.

China GMP for Pharmaceutical Packaging Materials (Draft for Comments)
Provides details on the proposed “Quality Management Specification for Pharmaceutical Packaging Materials Production,” outlining requirements for manufacturers and MAHs to ensure packaging quality and traceability.