WHO Prequalified Medicines List

The WHO Prequalified Medicines List is the publicly available database maintained by the WHO Prequalification Programme listing every medicine that has successfully completed WHO's quality, safety, and efficacy assessment, making those products eligible for procurement by UNICEF, UNDP, the Global Fund, UNFPA, and other UN-system and donor-funded buyers.

What is the WHO Prequalified Medicines List?

The List is the live output of the pqp for pharmaceutical products. It covers essential medicines in therapeutic categories that are priorities for global health funding: antiretrovirals for HIV treatment, antimalarials, antibiotics, antituberculosis medicines, reproductive health medicines including contraceptives, and a growing range of other essential medicines. For each listed product, the database shows the manufacturer, product name, dosage form, strength, manufacturing site, and prequalification status including any conditions or restrictions. The database is publicly searchable at extranet.who.int/pqweb and is updated in real time as products are added, varied, or removed.

UN agencies including unicef-supply-division and UNFPA require that medicines they procure appear on this List or hold an equivalent stringent regulatory authority approval. The Global Fund's ppm applies the same requirement. This makes the List a de facto market eligibility gate for the multi-billion dollar donor-funded medicines market, not merely a quality reference document.

Why the WHO Prequalified Medicines List matters for bidders

For a pharmaceutical manufacturer, appearing on the Prequalified Medicines List is the primary market access credential for UN and donor-funded procurement. Buyers reference the List before evaluating any offer: an unlisted product is typically excluded without further review. Manufacturers should monitor the List actively for two reasons: to confirm their own products remain listed and in good standing, and to track competitor products, since a competitor gaining or losing prequalification directly affects the competitive landscape in each therapeutic category.

FAQ

Can a medicine be removed from the WHO Prequalified Medicines List?

Yes. WHO can suspend or withdraw prequalification if a product is found to have quality deficiencies, if the manufacturer's facility fails a WHO inspection, or if new safety data emerges. Active monitoring of listing status is important for both buyers and competing suppliers.

Does every country accept WHO prequalification as a substitute for national registration?

No. WHO prequalification enables UN and donor procurement but does not automatically grant marketing authorisation in any country. National regulatory registration is a separate process required for commercial sale within each territory.

How do I find out whether a specific medicine is WHO prequalified?

The WHO prequalification database at extranet.who.int/pqweb is publicly searchable by product name, INN, manufacturer, or therapeutic category. The database is updated in real time as prequalification decisions are made.