The Strategic Role of WHO PQP in Global Procurement Systems
In the global fight against infectious diseases and in delivering universal health coverage, procurement of quality-assured medicines is a cornerstone strategy. The WHO Prequalification Programme (PQP) serves as a global mechanism for ensuring product quality, GMP compliance, and regulatory reliability. This article examines the strategic importance of WHO PQP for global procurement, highlighting its role in enabling donor confidence, facilitating market entry, and streamlining regulatory decision-making for essential health products.
What Is WHO PQP and Why Does It Matter?
WHO PQP was established in 2001 to assess the quality, safety, and efficacy of medicines and diagnostics used in priority disease areas such as HIV/AIDS, tuberculosis, malaria, and reproductive health. The program evaluates dossiers, inspects manufacturing sites, and publishes a list of prequalified products eligible for procurement by international health organizations and donors.
Core Objectives of WHO PQP in Procurement Ecosystems:
- Assure donors and public health buyers of product quality and GMP compliance
- Enable fast-track national registration through Collaborative Registration Procedure (CRP)
- Facilitate competitive tenders and supplier diversification
- Promote regulatory convergence and reduce duplication of assessments
WHO PQP as a Procurement Gatekeeper:
Many large global health buyers rely on WHO PQP status as a prerequisite for supplier eligibility:
- UNICEF: Procures vaccines, pediatric medicines, and reproductive health supplies
- GAVI: Supports vaccine access based on WHO PQ-approved products
- Global Fund: Accepts only WHO PQ or SRA-approved products
- MSF and UNDP: Use WHO PQ listings as procurement reference points
GMP Certification as a Pillar of WHO PQP:
One of the core strengths of WHO PQP is its rigorous GMP inspection process:
- Manufacturers must pass WHO inspections based on TRS 986 and TRS 961
- GMP certificates are globally recognized and form the basis of reliance by National Regulatory Authorities (NRAs)
- Validated processes, cleanroom design, QMS, and data integrity are assessed thoroughly
Impact on Market Access and Tender Participation:
Prequalification enables manufacturers to:
- Qualify for donor-funded procurement, opening access to high-volume, multi-country tenders
- Achieve faster product registration in LMICs through CRP
- Demonstrate international GMP recognition in regulatory filings
- Build brand credibility with procurers and development partners
WHO PQP and the Global Supply Chain:
- Supports donor assurance and risk mitigation for product quality
- Ensures uniform technical standards across diverse procurement landscapes
- Provides a repository of approved products and manufacturing sites
- Enables supply chain traceability and post-market surveillance via WHO partner networks
Importance for Local Manufacturers and Exporters:
- WHO PQP helps small- and medium-scale firms in LMICs gain entry into global markets
- Unlocks eligibility for pooled procurement initiatives and donation programs
- Enhances the manufacturer’s regulatory profile for eventual SRA filings
Link Between PQP and Stability Testing Standards:
Global procurement agencies require stability data that complies with WHO TRS 953 and ICH Q1A. WHO PQP mandates:
- Stability studies conducted in Zone IVb conditions for tropical markets
- Validated methods and data integrity for shelf-life determination
- Ongoing real-time monitoring and robust retest protocols
WHO PQP and Collaborative Registration Procedure (CRP):
- PQP acts as a foundation for accelerated registration in over 30 countries
- CRP allows national regulators to rely on WHO’s PQP outcomes
- This dramatically reduces duplication, timelines, and registration costs
Role of WHO PQP in Risk Management and Regulatory Reliance:
- Streamlines quality assurance processes across procurement programs
- Supports donor agencies in supplier evaluation and product selection
- Helps regulators in LMICs build confidence in imported medicines
- Mitigates risks related to substandard or falsified medicines in global tenders
Success Metrics Attributed to WHO PQP:
- Over 750 prequalified medicines, APIs, and diagnostics as of recent data
- Global Fund disbursements exceeding $50 billion have relied on PQP-backed procurement
- Over 100 countries recognize WHO PQP for expedited review
- Dozens of local manufacturers in Africa and Asia gained global reach through PQP
Challenges and Opportunities Ahead:
- Expanding PQP scope to cover broader therapeutic areas (e.g., cancer, NCDs)
- Enhancing digital integration for dossier tracking and e-CAPA systems
- Strengthening CRP adoption and feedback loops with NRAs
- Driving greater manufacturer engagement in prequalification for diagnostics and biologics
Conclusion:
The WHO Prequalification Programme is not merely a regulatory mechanism—it’s a global procurement enabler. It bridges the gap between quality assurance and access by ensuring only GMP-compliant, thoroughly assessed products reach the procurement pipelines of global health agencies. For manufacturers, PQP opens doors to international recognition, competitive tenders, and sustained partnerships with global buyers. For donors and public health leaders, it provides confidence that resources are invested in safe, effective, and reliable medical products.