How WHO Prequalification Enhances Market Access for Pharmaceutical Manufacturers

Global market access for essential medicines requires more than quality products—it demands recognition of regulatory compliance and supply chain trust. The WHO Prequalification Programme (PQP) serves as a powerful enabler of such access. Through a rigorous system of dossier evaluation and GMP inspections, WHO prequalification certifies that pharmaceutical products meet international standards. This article explores how WHO prequalification facilitates market entry, supports regulatory reliance, and opens procurement pathways for manufacturers worldwide.

What Is WHO Prequalification?

The WHO PQP assesses medicines, vaccines, diagnostics, and APIs to ensure their safety, efficacy, and quality. Once prequalified, a product is listed on the WHO prequalified medicines list, making it eligible for procurement by major global health organizations such as UNICEF, Global Fund, and GAVI.

Key Elements of WHO Prequalification:

• Evaluation of product dossiers in Common Technical Document (CTD) format
• GMP inspections of manufacturing facilities under WHO TRS 986 and 961
• Assessment of stability data in compliance with ICH Q1A
• Review of labeling, pharmacovigilance, and post-approval variation controls

How WHO PQP Enhances Market Access:

1. Opens Eligibility for Global Procurement

Prequalified products are immediately eligible for supply through international procurement channels:

• UNICEF supply chains for pediatric formulations and vaccines
• Global Fund procurement for HIV, TB, and malaria medicines
• GAVI-supported vaccine distribution programs
• Clinton Health Access Initiative (CHAI) supply partnerships

2. Accelerates National Registration via CRP

The Collaborative Registration Procedure (CRP) enables countries to rely on WHO PQ outcomes for rapid national registration:

• WHO inspection and dossier reviews are accepted by participating NRAs
• Time to market in LMICs is reduced from years to 90 days
• Manufacturers avoid redundant GMP inspections and full re-reviews

3. Strengthens GMP Credibility Across Borders

• Manufacturers audited by WHO gain recognition for robust quality systems
• WHO GMP certificates support registration efforts in non-CRP countries
• Manufacturers often use WHO PQ as a stepping stone toward SRA approval

4. Enhances Supply Chain Trust

Global buyers and health programs view WHO prequalified products as reliable, high-quality options that meet rigorous standards. This leads to:

• Faster adoption into national formularies
• Preferred supplier status in tender processes
• Reduced risk of product rejection at port of entry

Case Study: FPP Manufacturer in India

A mid-sized manufacturer of antiretroviral tablets in India obtained WHO prequalification in 2022. Within six months:

• The product was registered in Kenya, Zambia, and Nigeria through CRP
• A $4 million supply contract was secured via Global Fund
• WHO GMP status helped streamline a separate ANDA filing with the USFDA

Post-Prequalification Opportunities:

• Eligibility for supply agreements with WHO, MSF, and CHAI
• Inclusion in WHO’s Essential Medicines List (EML) recommendations
• Invitation to participate in regional pooled procurement tenders
• Faster approval of line extensions and co-packaged products

WHO PQ and GMP Synergy:

GMP inspections are integral to WHO PQ. Sites that pass inspection demonstrate maturity in areas such as:

• CAPA management and deviation trend analysis
• SOP traceability and version control
• Validated cleaning and change control systems
• Data integrity monitoring in QC labs

Barriers to Market Access Without WHO PQ:

• Ineligibility for UN and donor-funded procurement
• Higher inspection and regulatory burden for each target country
• Limited recognition of local GMP certification alone
• Delayed launch of essential medicines in high-burden markets

Tips for Manufacturers to Maximize WHO PQ Impact:

1. Select APIs from WHO-prequalified or SRA-approved sources
2. Align dossiers and SOPs with WHO guidance (TRS 986, 961)
3. Develop a clear market access plan linked to CRP countries
4. Train regulatory teams in both PQ and national submission pathways
5. Track post-PQ variations carefully to avoid requalification delays

WHO PQ in the Context of Global Harmonization:

• Supports reliance networks like SADC, EAC, and ASEAN
• Feeds into the African Medicines Agency (AMA) framework
• Encourages use of WHO inspection outcomes under regional joint assessments

Conclusion:

WHO Prequalification is more than a compliance badge—it’s a strategic asset for pharmaceutical manufacturers seeking global access and long-term credibility. By enabling regulatory reliance, expanding procurement eligibility, and building confidence in GMP compliance, PQP empowers companies to deliver quality-assured products to the world’s most underserved markets. In an era of increasing regulatory complexity, WHO PQ remains one of the most trusted and impactful routes to global market entry.