The encyclopedia · Strategy & Leadership · Strategic decision · 1987
WHO prequalification certified a medicine once so every buyer could trust it
Since 1987, WHO has vetted vaccines and medicines once — then UN agencies and countries buy from the approved list without re-testing.
World Health Organization
the move
Most of the world's countries have weak or inadequate regulatory systems for medicines and vaccines. In 1987 WHO launched the Prequalification Programme, originally to support UNICEF's vaccine procurement: assess a product once against global standards and make the verdict public.
The process combines dossier review, product testing, labelling checks and inspections of manufacturing sites; products that pass are listed as prequalified and become eligible for procurement by UN agencies, governments and partners, then monitored for the rest of their lifecycle.
The mechanism turned one assessment into a global market: more than 1,700 products are listed, donor-funded procurement runs to billions of dollars a year with vaccines nearly half, and the listings foster supplier competition and price reductions — while many countries use the list to guide their own purchases.
why it works
- One trusted assessment replaces hundreds of duplicative reviews.
- Prequalified products are immediately eligible for UN procurement.
- The public list lets weak regulators piggyback on WHO expertise.
- Supplier competition on a level playing field drives prices down.
what transfers
When many weak buyers face the same verification problem, build one trusted certification and share it: a single assessment serves every buyer, supplier competition rises, and prices fall.
what came after
The programme expanded from vaccines to medicines (2001), diagnostics and other devices, and its list became the reference that UN procurement agencies and countries rely on — with over 1,700 products listed by the end of 2025.
references
- Prequalification of medicines by WHO (fact sheet)
- Twenty-five years of the WHO vaccines prequalification programme (1987–2012): Lessons learned and future perspectives
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