WHO Prequalification: What It Means for Laboratory Products

WHO Prequalification is a service provided by the World Health Organization to assess the quality, safety, and efficacy of priority medical products. Understanding its importance helps laboratories make informed procurement decisions.

What is WHO Prequalification?

WHO Prequalification is a program that evaluates:

In vitro diagnostics (IVDs)
Medicines
Vaccines
Vector control products

Why It Matters

Quality Assurance: Products meet international standards
Regulatory Support: Facilitates national regulatory decisions
Procurement: Required by UN agencies and many donors
Access: Enables products to reach underserved markets

Prequalification Process

Manufacturer submits product dossier
WHO evaluates documentation
Site inspection of manufacturing facility
Performance evaluation (for IVDs)
Listing if requirements are met

Priority Products for IVD Prequalification

HIV diagnostics (rapid tests, viral load)
Malaria diagnostics
TB diagnostics
Hepatitis B and C tests
COVID-19 diagnostics

Our Commitment

Science Logistics Limited prioritizes WHO prequalified products where available, ensuring our customers receive diagnostics that meet international quality standards.