WHO prequalification: a quality stamp for global procurement

The World Health Organization (WHO) prequalification process is a global quality assurance service designed to ensure that medical products meet acceptable standards of quality, safety, and efficacy. Established in 2001, the programme originally focused on evaluating medicines for HIV/AIDS, driven partly by the need to provide international procurement agencies with a reliable way to assess generic treatments. It has since expanded to cover a broad range of priority health products. Often described as a global quality stamp, prequalification (PQ) does not replace national regulatory approvals, but it serves as a critical benchmark that allows international donors and low- and middle-income countries to purchase medical products in bulk with confidence.

What Products Are Covered?

The WHO prequalification programme focuses on medical products that address global public health priorities. These generally include medicines for HIV, tuberculosis (TB), malaria, hepatitis, and reproductive health. In addition to finished pharmaceutical products, the programme also evaluates active pharmaceutical ingredients (APIs) and some vaccines. Beyond medicines, the scope extends to vector control products, such as long-lasting insecticidal nets and indoor residual sprays used in malaria prevention, and in vitro diagnostics (IVDs) essential for detecting various infectious diseases.

The evaluation process is comprehensive. For medicines, WHO experts assess the product dossier, which includes data demonstrating that the generic version is bioequivalent to the originator product. They also inspect the manufacturing facilities to verify compliance with Good Manufacturing Practice (GMP). Once a product is prequalified, the manufacturer must commit to ongoing quality monitoring, and WHO conducts periodic re-evaluation and site inspections. This continuous oversight helps ensure that the quality stamp remains valid throughout the product's lifecycle.

How Donors and Procurement Agencies Rely on It

International procurement organizations, such as UNICEF, UNFPA, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and Gavi, the Vaccine Alliance, rely heavily on WHO PQ. These entities purchase massive quantities of medical products for distribution in low- and middle-income countries. To help ensure that funds are spent effectively and that patients receive safe, effective treatments, many donors mandate that products purchased with their grants must be WHO-prequalified.

This reliance on PQ streamlines the procurement process. Without a global standard like PQ, individual procurement agencies or countries would need to independently test and inspect every product from every supplier, which is costly and time-consuming. WHO PQ provides a standardized, reliable baseline. By aggregating demand for prequalified products, international agencies can negotiate better prices while maintaining strict quality standards. This creates a competitive market that encourages generic manufacturers to invest in quality improvements, knowing that prequalification unlocks access to global procurement channels.

Relationship to National Regulatory Approval

A key distinction exists between WHO prequalification and national marketing authorization. A WHO PQ certificate does not grant a product legal permission to be sold or distributed in a specific country. Every sovereign nation has its own medicines regulatory authority, which is ultimately responsible for approving products for its domestic market.

However, the relationship between WHO PQ and national regulators is highly collaborative. Many national regulatory authorities lack the resources to independently evaluate every medicine that enters their market. Recognizing the rigor of the WHO process, many regulators use WHO PQ as a reference point to expedite their own approvals. WHO facilitates this through collaborative registration procedures, where the dossier used for prequalification is shared with national authorities. Because WHO has already rigorously assessed the manufacturing standards and clinical data, national regulators can rely on this assessment to save time and resources, leading to faster access to essential medicines.

Prequalification and the South African Context

In South Africa, the South African Health Products Regulatory Authority (SAHPRA) is the body responsible for evaluating and registering medicines, as well as regulating the Single Exit Price. While WHO PQ is not a substitute for SAHPRA registration, SAHPRA frequently relies on collaborative review pathways and uses WHO assessments to streamline domestic approvals where appropriate. South Africa's regulatory system is also recognized by WHO as a Listed Authority, meaning its regulatory standards are highly regarded globally.

The WHO PQ system primarily exists to safeguard the global supply chain against substandard and falsified medicines, ensuring that bulk procurements reach patients safely. For healthcare professionals and patients verifying the domestic status of a specific treatment, confirming that a product has been registered by SAHPRA and checking its regulated price can be done using the HealthSA search tool. This distinction highlights the complementary roles of global quality assurance and national regulatory oversight.