WHO PQP Public Assessment Reports: Format, Purpose, and Strategic Use

One of the hallmarks of the WHO Prequalification Programme (PQP) is transparency. This is exemplified through the publication of Public Assessment Reports (PARs), which summarize the outcome of the WHO PQ evaluation of pharmaceutical products. These documents serve as key tools for regulators, procurers, and manufacturers by offering a concise view of dossier evaluations and GMP compliance. This article unpacks the structure of WHO PARs and their utility in strengthening regulatory convergence and market access strategies.

What Is a WHO Public Assessment Report?

A Public Assessment Report (PAR) is a summary document published by WHO after successful prequalification of a medicine, API, or vaccine. It reflects the scientific assessment of the submitted dossier, including product quality, GMP findings, and benefit-risk conclusions. It enhances transparency and supports regulatory reliance by National Regulatory Authorities (NRAs).

Purpose of WHO PQP Public Assessment Reports:

• Promote transparency in regulatory decision-making
• Enable reliance and accelerated registration through Collaborative Registration Procedure (CRP)
• Provide confidence to procurement agencies regarding product quality
• Support global harmonization of dossier evaluation standards

Structure of a Typical WHO Public Assessment Report (PAR):

1. Product and Manufacturer Information

• Product name, strength, dosage form
• Applicant name and manufacturing site address
• Prequalification number and date

2. Summary of Product Characteristics

• Indications and dosage recommendations
• Pharmacological class and mechanism of action
• Target disease or therapeutic category

3. Assessment Summary

This is the core section of the PAR, highlighting WHO’s evaluation of the submitted dossier:

• Quality review outcomes
• Critical formulation data
• Validation of manufacturing process
• Stability testing results and shelf-life assignment
• Review of packaging and labeling

4. GMP Compliance Statement

• Summary of the GMP inspection outcome
• Facility audit details (location, date, compliance level)
• CAPA summary if any deficiencies were noted

5. Benefit-Risk Evaluation

• Final WHO recommendation and rationale
• Public health value of the product
• Conclusion on risk-benefit balance

6. Annexes and References

• Summary of variations (if applicable)
• Relevant WHO TRS and guideline references
• Link to the WHO list of prequalified products

Where Are WHO PARs Published?

PARs are publicly accessible on the official WHO PQ website. Each product’s PAR is linked to its listing in the WHO prequalified medicines database.

How Regulatory Authorities Use PARs:

• Support national registration under the Collaborative Registration Procedure (CRP)
• Reduce duplication of full dossier evaluations
• Confirm that WHO GMP inspections have already assessed the facility
• Verify labeling, composition, and shelf-life information

Usefulness for Manufacturers:

• Serves as a regulatory endorsement to support product registration in new markets
• Helps align marketing authorizations across multiple geographies
• Demonstrates product compliance to donors, NGOs, and national tenders
• Supports faster contract award and SOP alignment with global QA norms

PAR vs. Full Dossier Access:

While the full CTD dossier remains confidential, the PAR provides sufficient data to support informed decision-making by stakeholders. It protects intellectual property while fostering transparency.

Stability Data Insights in PARs:

WHO PQP PARs include detailed analysis of long-term and accelerated stability data to justify proposed shelf-life. The report specifies the climatic zone tested (e.g., Zone IVb), testing conditions, and the product’s final labeled expiry. This is crucial for procurers in tropical markets who rely on robust stability claims.

Regulatory Reliance and the Role of PARs:

Regulators in LMICs can leverage the PAR as an official, scientifically reviewed summary to accelerate registration timelines, reduce workload, and strengthen mutual trust. Many countries in Africa, Asia, and Latin America now use PARs as part of their fast-track approval processes.

Common Observations from WHO PARs:

• Products often require minor label modifications for approval
• API and FPP specifications may be tightened post-review
• Additional data requests on process validation or cleaning validation
• Recommendations on pharmacovigilance reporting post-market

Tips for Leveraging WHO PARs Effectively:

1. Include a copy of the PAR in national registration submissions
2. Ensure your CRP applications reference the correct PQ number and PAR
3. Share PARs with procurement officers during tendering
4. Align internal quality documents with the WHO-stated specifications
5. Train regulatory teams on interpreting and presenting PAR data

Conclusion:

The WHO PQP Public Assessment Report is a vital transparency and regulatory harmonization tool. By summarizing complex dossier and GMP inspection outcomes into a concise, public format, PARs build trust, accelerate national registration, and enable global health stakeholders to make informed decisions. For pharmaceutical manufacturers and regulators alike, mastering the structure and strategic use of WHO PARs is essential to navigating the evolving landscape of global GMP compliance and medicine access.