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Published: 2025/12/24 14:44:11

WHO Prequalification and EUL: Ensuring Access to Quality diagnostics

The World Health Organization (WHO) emphasizes the critical role of decentralized, quality-assured testing in achieving universal health coverage and strengthening global health security. Central to this effort are the WHO Prequalification programme and its Emergency Use Listing (EUL) procedure, which accelerate access to vital health products, notably in low- and middle-income countries (LMICs).

understanding WHO Prequalification

For many years, the WHO Prequalification Programme has been instrumental in improving access to quality health products in LMICs. The program rigorously assesses the quality, safety, and effectiveness of medicines, vaccines, diagnostic tools, and vector control products. This assessment isn’t just about verifying standards; its about building confidence in the products used to protect global health.

Benefits of WHO Prequalification

• Facilitated procurement: Prequalification enables multilateral organizations, like UNICEF and the Global Fund, to confidently purchase quality-assured products. The Global Fund, for example, relies heavily on prequalified products to combat diseases like HIV, tuberculosis, and malaria.
• Guidance for Regulatory authorities: The program provides valuable guidance to developing regulatory authorities that may lack the resources to conduct their own comprehensive evaluations. This helps build local capacity for quality control.
• Increased Access: By streamlining the approval process and building trust, prequalification ultimately increases access to essential health products for those who need them most.

Emergency Use Listing (EUL) During Public Health Emergencies

The WHO’s Emergency Use Listing (EUL) is a special procedure used during public health emergencies of international concern.EUL conducts risk-based assessments of products to meet urgent public health needs.This allows for the rapid deployment of potentially life-saving tools, even before full regulatory approval is granted.

How EUL Works

During a public health emergency, the EUL process involves:

• Accelerated Review: A streamlined review process focusing on critical quality, safety, and efficacy data.
• Risk-based Assessment: evaluating the benefits of using a product against the risks,considering the emergency context.
• Conditional Approval: Granting temporary approval for use during the emergency, with ongoing monitoring and data collection.

The Importance of Decentralized, Quality-Assured Testing

The WHO’s broader diagnostics strategy underscores the necessity of decentralized testing. Bringing testing closer to the patient – rather than relying solely on centralized laboratories – improves access, reduces turnaround times, and enables faster treatment decisions. Tho, decentralization must be coupled with robust quality assurance mechanisms, like WHO prequalification and EUL, to ensure accurate and reliable results. This strategy is vital for both universal health coverage and global health security.

Key Takeaways

• WHO Prequalification ensures the quality,safety,and effectiveness of health products in LMICs.
• The EUL procedure accelerates access to vital tools during public health emergencies.
• Decentralized testing, combined with quality assurance, is crucial for improving healthcare access and security.
• Both programs support the WHO’s goals of universal health coverage and global health security.

Looking ahead, the WHO Prequalification Programme and EUL will continue to play a vital role in ensuring equitable access to high-quality health products. Ongoing