Leveraging WHO’s Collaborative Registration Procedure (CRP) for GMP Compliance and Global Market Access

For pharmaceutical manufacturers aiming to expand access to essential medicines, navigating diverse national registration systems can be challenging. The WHO Collaborative Registration Procedure (CRP) offers a powerful mechanism to streamline regulatory approvals while ensuring GMP compliance. This article explores the structure, function, and benefits of the WHO CRP, its role in global market access, and how it contributes to regulatory convergence and inspection reliance.

What Is the WHO Collaborative Registration Procedure?

Launched in 2013, the WHO CRP is a voluntary mechanism that allows national regulatory authorities (NRAs) to accelerate the registration of WHO-prequalified products or products approved by Stringent Regulatory Authorities (SRAs). It relies on the principle of regulatory reliance—using the results of prior evaluations and inspections to support national decision-making.

Products Eligible for WHO CRP:

• Finished Pharmaceutical Products (FPPs) prequalified by WHO
• Vaccines and biologicals approved by WHO PQ
• Medicines approved by SRAs with a validated reliance agreement

Objectives of CRP in the Context of GMP Compliance:

• Reduce duplication of GMP inspections and dossier evaluations
• Strengthen regulatory capacity in low- and middle-income countries
• Accelerate market access for quality-assured products
• Ensure alignment with WHO PQ GMP requirements

Structure of the WHO CRP Process:

1. Expression of Interest and Country Participation

• NRAs register for participation in CRP via WHO
• Manufacturers express willingness to participate and consent to share confidential information with participating NRAs

2. Dossier Submission

• Manufacturers submit the same CTD-format dossier as approved under WHO PQ
• National variations (e.g., local labeling, language) are allowed
• SOPs submitted must align with WHO TRS 986 and 961

3. Regulatory Review and WHO Support

• NRAs access the WHO assessment report and GMP inspection outcome
• WHO provides clarifications or technical guidance if needed
• NRAs conduct abbreviated reviews based on WHO conclusions

4. National Decision and Approval

• Registration decisions are typically issued within 90 days
• CRP avoids re-inspections unless significant contextual differences exist
• Post-approval variations must also align with WHO variation policies

CRP’s Contribution to GMP Harmonization:

The CRP reinforces GMP consistency by enabling countries to:

• Adopt WHO PQ inspection findings and site audits
• Implement WHO guidelines like TRS 986 and 961 across national systems
• Train their regulators using WHO GMP inspection checklists

Stability Testing Considerations in CRP:

Stability data from the WHO-prequalified dossier is fully leveraged during CRP reviews, provided it aligns with the receiving country’s climatic zone:

• Zone IVb (30°C/75% RH) data is often preferred for tropical countries
• All stability studies must comply with ICH Q1A(R2)
• Data integrity and traceability are key review elements during CRP

Benefits of WHO CRP for Manufacturers:

• Expedited national product registration (typically within 90 days)
• Minimized need for country-specific GMP inspections
• Reduced workload from dossier customization
• Faster access to donor-funded procurement channels
• Improved predictability and transparency in market entry

Benefits of CRP for Regulatory Authorities:

• Leverage international evaluations without compromising autonomy
• Focus resources on priority assessments and pharmacovigilance
• Capacity building through exposure to WHO PQ technical reviews

Challenges in CRP Implementation:

• Limited digital infrastructure for information sharing
• National variations in pharmacopoeial standards and GMP interpretations
• Delays in manufacturer consent or document submission
• Misalignment of post-approval variation timelines between WHO and NRAs

Best Practices to Optimize CRP Participation:

1. Ensure complete and compliant WHO-prequalified dossiers
2. Train regulatory affairs teams on country-specific CRP nuances
3. Maintain up-to-date GMP certificates and inspection reports
4. Engage local agents with experience in WHO reliance procedures
5. Build systems for harmonized post-approval variation tracking

Impact of CRP on Global Health Procurement:

CRP significantly shortens the time between WHO PQ and product availability for public health programs in LMICs. As more NRAs align with WHO’s risk-based GMP model and regulatory reliance strategies, CRP strengthens the integrity and speed of global supply chains.

Conclusion:

The WHO Collaborative Registration Procedure is a cornerstone of regulatory convergence and efficient GMP oversight. It allows manufacturers to capitalize on prequalification efforts and NRAs to benefit from WHO’s rigorous evaluation framework. As CRP adoption grows, it paves the way for faster, safer access to quality medicines across the globe—especially where they are needed most.