WHO PQP vs. Stringent Regulatory Authority Approvals: Key Differences and Strategic Implications
The global pharmaceutical regulatory ecosystem includes multiple pathways for product approval and GMP oversight. Among the most prominent are the WHO Prequalification Programme (PQP) and approvals by Stringent Regulatory Authorities (SRAs) such as the USFDA, EMA, MHRA, and PMDA. While both aim to assure product quality, safety, and efficacy, they differ significantly in scope, regulatory frameworks, and strategic application. This article compares the two systems across key parameters and outlines when each is most suitable for manufacturers.
Definition and Purpose:
WHO Prequalification Programme (PQP)
- A global assessment initiative led by the World Health Organization
- Focuses on medicines and diagnostics for high-priority public health needs
- Supports UN procurement, regulatory reliance, and access in LMICs
Stringent Regulatory Authorities (SRAs)
- National or regional agencies with robust regulatory frameworks (e.g., USFDA, EMA, PMDA)
- Evaluate all classes of pharmaceutical products across therapeutic areas
- Approval is required for marketing in high-income countries (HICs)
GMP Standards and Inspections:
WHO PQP
- Follows WHO TRS 986 and 961 for GMP principles
- Focus on WHO-priority diseases (HIV, TB, malaria, etc.)
- Risk-based inspection frequency and joint audits with NRAs
- Applicable to both public and private manufacturers and QC labs
SRA Approval
- Complies with ICH Q7–Q10, CFR Part 211 (US), or EU GMP Volume 4
- Inspections include full manufacturing lifecycle with CAPA enforcement
- Product recalls and import alerts are publicly listed
- Frequent unannounced inspections with significant legal implications
Dossier Evaluation Process:
WHO PQP
- Dossiers submitted in CTD format
- Focus on quality, safety, and efficacy aligned with WHO guidelines
- Streamlined evaluation for FPPs, APIs, vaccines, IVDs
- Outcome summarized in a Public Assessment Report (PAR)
SRA Approval
- Dossiers reviewed with product-specific FDA or EMA guidelines
- Includes in-depth review of clinical data and patient risk-benefit analysis
- Mandates REMS (Risk Evaluation and Mitigation Strategies) for high-risk drugs
- Approval results in product market authorization or license
Inspection Scope and Approach:
WHO PQP
- Targeted to essential medicines for global health programs
- Joint inspections with NRAs and regional partners
- Includes review of stability studies, quality systems, and manufacturing controls
- Focuses on risk mitigation and capacity building
SRA
- Broad coverage across all dosage forms and risk categories
- Advanced tools: statistical sampling, computer system validation, and forensic audits
- High focus on data integrity, serialization, and pharmacovigilance systems
- Enforcement includes warning letters, 483s, and consent decrees
Post-Approval Surveillance:
WHO PQP
- Annual product review (APR) submissions
- Monitoring through WHO Collaborative Registration Procedure (CRP)
- Surveillance testing via prequalified QC labs
- Variations submitted via WHO variation guidance
SRA
- Ongoing compliance audits and periodic safety updates (PSURs)
- Post-market clinical commitments and Phase IV trials
- Rigorous pharmacovigilance and risk mitigation plans
- Mandatory reporting of adverse drug events
Global Recognition and Market Implications:
WHO PQP
- Accepted by 100+ countries for UN-based procurement
- Backbone of supply to GAVI, UNICEF, Global Fund, and MSF
- Supports access to tenders in low- and middle-income countries
SRA
- Grants access to regulated markets like the US, EU, Japan, Canada, and Australia
- Often required for commercial scale-up and investor support
- Serves as a gold standard for WHO reliance and CRP pathways
Timeframe and Cost:
WHO PQP
- Approx. 6–12 months from submission to listing (product dependent)
- No filing fees, but manufacturers bear inspection travel and CAPA costs
- Resource-light for small to mid-sized manufacturers
SRA
- Average 12–24 months for approval (may vary by country)
- Significant application and user fees (e.g., PDUFA for USFDA)
- Higher documentation and clinical trial requirements
When to Pursue WHO PQP vs. SRA Approval:
- WHO PQP: Ideal for essential medicines intended for global health procurement or LMIC registration
- SRA Approval: Required for commercial access to HICs and higher-margin private markets
- Many manufacturers pursue WHO PQP first, then leverage it to expand via CRP and later apply to SRAs
Conclusion:
Both WHO PQP and SRA approvals serve essential roles in the global pharmaceutical ecosystem. While WHO PQP ensures broad public health access and supports regulatory harmonization, SRA approvals unlock access to lucrative markets and drive innovation standards. For manufacturers, aligning product strategy with the appropriate pathway—WHO PQP, SRA, or both—can maximize impact, revenue, and regulatory credibility across diverse markets.