WHO Prequalification was born from the need to supply quality-assured health products ― in-vitro diagnostics, active pharmaceutical ingredients, finished pharmaceutical products, immunization devices and vaccines ― particularly for use in low-income countries.
Its vision is simple: good-quality health products for everyone. Its mission is to ensure timely availability of quality-assured health products for the prevention, diagnosis and treatment of priority diseases, through the assessment of the quality, safety and efficacy/performance of these products, with a focus on their suitability for use in resource-limited settings.
For each product type, prequalification is based on application of unified standards of quality, safety and efficacy/performance to product dossier assessment, an inspection of the corresponding manufacturing sites, as well as other product-specific elements of evaluation, such as a laboratory evaluation (for diagnostics) or inspection of the clinical sites (for medicines).
Following prequalification, WHO and a national regulatory authorities can apply a collaborative procedure to minimize the time taken to register a product.
WHO Prequalification also conducts extensive training activities for regulators and manufacturers, provides technical assistance to manufacturers and supports the building of national capacity for testing and monitoring of health products ― including through prequalification of medicines quality control laboratories ― to ensure that health product quality is not only attained but maintained.
UNAIDS, UNICEF, UNFPA, the World Bank ― and many other organizations ― consider WHO prequalification to be a concrete contribution to the United Nations priority goal of addressing high-burden diseases in countries with limited access to quality health products.