global tenders by UN agencies

Recognition by national regulatory authorities (NRAs) in low- and middle-income countries

Enhanced credibility and trust in global markets

Streamlined registration in participating countries via collaborative procedure

It is particularly vital for manufacturers of anti-TB, HIV, malaria, reproductive health, and pediatric medicines. Vaccines and in-vitro diagnostics also follow similar PQ pathways.

3. WHO PQ Process: Step-by-Step

Step 1: Eligibility and Expression of Interest (EOI)

WHO publishes EOIs for specific medicines or categories. Manufacturers must meet the eligibility criteria outlined in the EOI document and submit an application expressing interest.

Step 2: Dossier Submission

The applicant submits a full Common Technical Document (CTD)-format dossier including:

• Module 1: Administrative information
• Module 2: Quality overall summary
• Module 3: Drug substance and product details
• Module 4: Non-clinical study reports
• Module 5: Clinical data (bioequivalence, efficacy/safety trials)

Dossiers must conform to WHO TRS guidelines and should be prepared by a cross-functional regulatory team.

Step 3: Screening and Assessment

WHO performs a technical review of the dossier, which can take 90–180 days. Queries are raised during this period, and responses must be submitted in a timely and structured format.

Step 4: GMP Inspection

WHO schedules an on-site GMP inspection of the manufacturing and testing facilities. The site is evaluated against WHO GMP standards as described in WHO TRS 986 Annex 2.

Step 5: Decision and Listing

If the product and site pass all evaluations, WHO grants prequalification status and lists the product in the WHO PQ database.

Access the latest PQ SOPs and inspection templates from Pharma SOP.

4. Key Compliance Requirements

To meet PQ standards, manufacturers must ensure:

• GMP Compliance: Facilities must be WHO GMP certified or compliant with equivalent standards.
• Validated Analytical Methods: All methods for release and stability testing must be fully validated per ICH Q2(R1).
• ICH Stability Studies: Products must be supported with real-time and accelerated stability data. Refer to Stability Studies for detailed ICH zone guidance.
• Bioequivalence Studies: Comparative studies with reference products are mandatory for generic applications.
• Packaging and Labeling: Should be suitable for target markets, including multilingual inserts and tamper-evident seals.
• Pharmacovigilance (PV): A functioning PV system is essential with designated personnel and reporting protocols.

5. ERP Pathway: Emergency Use Evaluation

In certain public health emergencies, WHO offers the ERP (Expert Review Panel) pathway to fast-track approval for unregistered or prequalified products. This route is temporary and subject to strict post-market commitments.

ERP is typically used during outbreaks or supply crises where there’s a need for rapid access to essential drugs.

6. Common Challenges in PQ Compliance

• Incomplete Dossiers: Missing quality summaries, poor study documentation
• Inspection Non-Compliance: Gaps in documentation, deviation management, or data integrity
• Communication Delays: Inadequate response timelines to WHO queries
• Outdated Processes: Non-updated validation, calibration, or cleaning records

Many of these issues can be avoided through proper internal audits and mock inspections. Resources are available at Pharma GMP.

7. Post-Prequalification Obligations

Once PQ status is granted, the manufacturer must maintain it by:

• Submitting annual Product Quality Reviews (PQR)
• Reporting adverse events and batch recalls
• Seeking approval for post-approval changes
• Responding to WHO post-market surveillance reports

Failure to meet post-PQ obligations can result in suspension or delisting.

8. Best Practices for WHO PQ Readiness

• Form a dedicated WHO PQ Taskforce including regulatory, QA, QC, and manufacturing leads
• Pre-audit your manufacturing site using WHO inspection checklists
• Train teams on WHO dossier structure and query handling
• Use eCTD software for organized and traceable submissions
• Engage experienced consultants familiar with WHO communication protocols

Need help preparing? Download prequalification roadmap templates from Pharma Regulatory.

9. WHO Prequalification for Other Products

The PQ program also covers:

• Vaccines: Assessed for efficacy, cold chain stability, and GMP
• In-Vitro Diagnostics (IVDs): Evaluated for performance and quality control systems
• Medical Devices: Limited list under WHO PQS (Performance, Quality, Safety)

Each product type has separate guidance and assessment formats.

10. Conclusion

WHO Prequalification is a globally respected certification that can unlock major business opportunities in the global public health supply chain. While the path is rigorous, the benefits in terms of market access, credibility, and international recognition make it worthwhile.

By adopting best practices in GMP, dossier preparation, and regulatory inspection readiness, pharmaceutical companies can successfully achieve and maintain WHO PQ compliance. Consistency, transparency, and proactive communication with WHO are the keys to success.

For templates, audit tools, and PQ updates, visit Pharma Validation and Clinical Studies.