WHO Prequalification Programme (PQP)

The WHO Prequalification Programme (PQP) is WHO's independent assessment and listing process that certifies health products, including medicines, vaccines, in-vitro diagnostics, immunisation devices, and vector control products, meet international standards of quality, safety, and efficacy acceptable for procurement by UN agencies and donor-financed health programmes worldwide.

What is the WHO Prequalification Programme?

The PQP was established to give UN agencies and their donor partners confidence that the health products they procure are of acceptable quality regardless of where they are manufactured. Before the programme, buyers faced significant risk of substandard or falsified products entering supply chains. WHO prequalification addresses this by evaluating the manufacturer's facility, quality systems, product dossier, and clinical data against WHO-defined standards. Products that pass are listed on the WHO prequalified products database, which covers more than 1,700 products across regulated health commodity categories.

The practical consequence is that unicef-supply-division, UNFPA, UNDP, and the Global Fund's ppm either require or strongly prefer WHO prequalification status for any regulated health product they procure. A vaccine, antiretroviral medicine, or diagnostic that is not WHO prequalified is, in most cases, ineligible to compete for UN system procurement. This makes the PQP not merely a quality certification but a market access requirement for the entire $10-plus billion annual UN health procurement market. The who-prequalified-medicines-list and who-prequalified-vaccines-list are the publicly searchable outputs of the programme.

Why the WHO Prequalification Programme matters for bidders

For any pharmaceutical manufacturer, vaccine producer, or diagnostics company targeting the UN or donor-funded global health market, WHO prequalification is the single most important regulatory milestone to achieve. Without it, the largest buyers in the market cannot legally or practically consider your product. The prequalification process is rigorous and time-consuming, typically taking 12 to 24 months for a first product, but it opens access to a global market that no national regulatory approval alone can unlock. Manufacturers should treat PQP submission as a strategic investment, not a compliance formality, and engage with the process early relative to their commercial timelines.

FAQ

What product categories are covered by the WHO Prequalification Programme?

The PQP covers medicines (including antiretrovirals, antimalarials, antibiotics, and reproductive health medicines), vaccines, in-vitro diagnostics, immunisation devices such as syringes and cold chain equipment, and vector control products such as insecticide-treated nets.

Is WHO prequalification the same as approval by a national regulatory authority?

No. WHO prequalification is an international assessment designed specifically for procurement by UN agencies and donor programmes. It complements but does not replace national regulatory approvals, which are required for marketing in each country.

How long does WHO prequalification take?

The timeline varies by product and the completeness of the submission dossier. First-time applications for a new product typically take 12 to 24 months. Prequalification of a product already approved by a stringent regulatory authority (such as EMA or US FDA) may follow an accelerated pathway.