Navigating Combination Product Regulations In Child-Resistant Packaging

Combination products represent one of the fastest-advancing areas in modern healthcare, merging drugs, medical devices, and biologics into single, effective therapeutic solutions. However, as these products gain clinical importance, ensuring safe and compliant child-resistant packaging becomes a critical Regulatory obligation—especially when products are intended for home use or frequent handling.

For manufacturers and marketers, non-compliance in packaging can result in product recalls, import refusals, market withdrawals, and severe patient safety risks, particularly for children. This blog explores how life sciences companies can strategically navigate combination product packaging compliance, focusing on child-resistant systems, global Regulations, and best-practice implementation.

Why Child-Resistant Packaging Matters

Combination products are increasingly being supplied in forms such as:

• Auto-injectors
• Transdermal patches
• Prefilled syringes
• Inhalation devices
• Multi-dose oral and dermal formulations

These products may contain high-potency active ingredients, making accidental paediatric access a serious risk. Child-resistant (CR) packaging ensures safety without compromising usability for adults and patients with limited dexterity.

Recent regulatory recalls highlight that traditional CR packaging methods may fail when applied directly to complex combination product formats. A design-driven, standards-aligned approach is essential.

Regulatory Frameworks Governing Child-Resistant Packaging

United States (FDA)

• Combination products are regulated based on Primary Mode of Action (PMOA) across:
  • CDER (Drugs)
  • CDRH (Devices)
  • CBER (Biologics)
• Child-resistant packaging is required under the Poison Prevention Packaging Act (PPPA).
• Packaging validation must comply with 16 CFR 1700.20 testing methodologies.

European Union

• Conformance is guided by relevant standards and EU MDR / EU IVDR where applicable.
• EN 14375 and BS EN 862 cover pharmaceutical and non-pharmaceutical CR packaging safety.

International (ISO)

• ISO 8317 outlines performance standards and test procedures for re-closable child-resistant packaging globally.

Key Design Considerations

Developing CR packaging for combination products requires balancing:

•  Safety (child protection)
•  Accessibility (senior & patient usability)
•  Device/drug functionality

Innovative CR design approaches include:

• Dual-action or two-step opening mechanisms
• Push-and-twist closures
• Moisture-triggered or heat-activated release systems
• Customized perforated blister patterns
• Human-factors engineered interface elements

Human Factors Engineering (HFE) and Usability Studies are crucial to ensure the packaging:

• Cannot be easily opened by children
• Does not create barriers to patient adherence

Testing & Validation Requirements

Compliance requires structured testing, including:

Testing must be repeatable, documented, and consistent with regulatory submission requirements.

Regulatory Documentation for Submission

A complete Regulatory submission for a combination product with CR packaging should include:

• Full packaging design specifications
• Material integrity and compatibility data
• Child-resistant and senior usability test reports
• Stability performance data
• Human factors validation reports
• Risk management files & mitigation strategy

How Regulatory Partners Strengthen Compliance

Partnering with experienced Regulatory experts, like Maven Regulatory Solutions, provides:

Conclusion

As combination products continue to advance healthcare delivery, child-resistant packaging stands as a non-negotiable safety and compliance pillar. Success requires technical design innovation, rigorous standards alignment, and strategic Regulatory planning.

With the right regulatory partner, life sciences organizations can:

• Ensure compliance
• Reduce market entry risks
• Enhance patient safety
• Improve market confidence
• Accelerate time-to-market

Maven Regulatory Solutions supports organizations across the full product lifecycle — from concept and design to Regulatory submissions and post-market compliance.