NMPA Releases Guideline on Appropriate Pharmaceutical Packaging Sizes to Reduce Drug Waste & Over-Packaging

On June 1, 2026, China’s National Medical Products Administration (NMPA), through its Center for Drug Evaluation (CDE), released the “Guideline for the Development of Appropriate Pharmaceutical Packaging Sizes,” effective immediately.

While non-binding, the guideline clarifies expectations for how packaging size should be addressed during drug development. It reflects a shift toward earlier, more structured evaluation of packaging decisions, balancing clinical use, patient convenience, economic efficiency, and environmental impact.

Designing Packaging Around Clinical Use

The guideline reflects broader policy efforts to reduce pharmaceutical waste and improve healthcare resource efficiency. Aligned with national initiatives such as the “Implementation Plan for Conserving Pharmaceutical Resources and Curbing Pharmaceutical Waste” (2023), it reframes packaging from a primarily protective function to a factor that also affects adherence, workflow efficiency, treatment cost, and environmental impact.

Accordingly, the guideline reinforces packaging materials, container systems, and pack sizes should be considered during pharmaceutical development rather than solely as downstream commercial decisions.  The guideline encourages applicants to  scientifically justify packaging size decisions  through an integrated assessment of clinical, scientific, and operational factors. This also reinforces the need for earlier cross-functional alignment across regulatory, clinical, manufacturing, and commercial teams.

1. Packaging Must Reflect Dosing Reality

Because packaging is expected to follow clinical use, it must be built around actual dosing and treatment structure, including:

• Administration frequency and dose per use
• Titration or dose adjustment requirements
• Dosage form and product configuration

This is particularly important where treatment is not uniform, such as therapies with variable duration, individualized dosing, or use across different care settings.

Accordingly, applicants are expected to demonstrate — using product-specific clinical evidence and real-world use patterns — that packaging design supports safe and effective use while maintaining system efficiency.

2. Pack Size Should Match Treatment Duration

The same clinical-use logic extends to pack sizing: if packaging is intended to reflect real-world use, pack quantities should align with treatment duration and dosing patterns.

For short-term therapies, pack sizes should closely match the expected treatment course. This reduces leftover medicines after completion, limiting waste and reducing risks associated with storage or unintended use.

For long-term therapies, larger pack sizes may be appropriate where they reflect stable ongoing treatment.

Indicative ranges include:

• Two-week supplies may be suitable for continuous daily therapies
• One-month supplies may be appropriate for stable chronic treatment

The intent is to balance adherence, convenience, and resource efficiency, while reducing unnecessary packaging and pharmacy visits (particularly for medicines intended for outpatient use or patient self-administration).

3. Information Design Must Prevent Use Errors

Once packaging is tied to real-world use, the clarity of critical information becomes safety-critical.

Key details such as manufacturing and expiry dates must therefore be:

• Immediately visible in the packaging layout
• Clearly distinguishable from surrounding information
• Easy to read under routine handling conditions

The guideline reinforces this by recommending contrasting background colours for printed information, improving legibility where rapid identification is required. This is not treated as a cosmetic design issue, but as a direct extension of safe use in clinical and patient environments.

4. Efficiency and Sustainability Follow from Simplified Design

The same logic of “design for real use” also extends to reducing unnecessary packaging complexity. While maintaining requirements for product quality, stability, transport integrity, and patient safety, packaging should avoid structural and material excess that does not serve clinical use.

Applicants are therefore encouraged to minimize:

• Excess volume and weight
• Multiple or redundant layers
• Non-essential components

This is not framed purely as an environmental measure. The guideline explicitly links packaging complexity to operational burden, particularly for healthcare professionals who must unpack, handle, and dispose of materials. Simplifying packaging is therefore positioned as a way to improve both workflow efficiency and resource efficiency.

Implications for Drug Registration Applicants

By shifting packaging decisions from a downstream formatting step to an early-stage design element, the guideline brings packaging configuration — particularly pack size and unit structure — into core development planning alongside dose selection, stability assessment, and usability considerations.

This is particularly relevant in the following contexts:

• Products introducing new dosage forms or packaging configurations: where applicants need to justify that the proposed packaging appropriately supports the intended clinical use.
• Products with elevated waste or misuse risk: including unusually large pack sizes or medicines associated with significant wastage or partial-use discard in practice
• Products with high operational handling complexity: including hospital-use medicines or packaging formats where multi-step or bulky packaging may adversely affect handling efficiency and clinical workflow

Across these scenarios, the expectation is that applicants can justify why a given pack structure is appropriate in relation to real-world use conditions—not on the basis of manufacturing convenience or commercial logic.

For companies managing large and diverse pharmaceutical portfolios, this extends into lifecycle governance. Packaging should be periodically reviewed to ensure configurations remainaligned with current clinical practice, continue to minimize avoidable waste, and support efficient handling within  healthcare settings.

Where misalignment is identified, packaging changes can be submitted under the Administrative Measures for Post-Approval Changes to Drug Products (Trial) and the relevant supporting technical guidance.

Final Thoughts

The CDE guideline elevates pharmaceutical packaging from a logistical consideration to a strategic development issue closely tied to clinical practice, patient experience, healthcare efficiency, resource conservation, and environmental stewardship.

As China’s regulatory framework places increasing emphasis on lifecycle management and waste reduction, packaging development should be considered an integral component of overall pharmaceutical development alongside formulation, manufacturing, and quality planning.

In this context, Cisema can support companies in interpreting these expectations and translating them into development and registration strategy, helping ensure packaging decisions remain both compliant and operationally optimal across the product lifecycle.

To discuss how the new guideline may affect your products and development programs, contact Cisema today.

Further Information

• Explore Cisema’s pharmaceutical consulting services.

References

• Announcement from the Center for Drug Evaluation of the National Medical Products Administration on Issuing the "Guiding Principles for Developing Suitable Drug Packaging Specifications" (2026 No. 37)