History and Mission of WHO Prequalification

Today, we have prequalified almost 1,500 products — in vitro diagnostics (IVDs), male circumcision devices, medicines, vaccines, immunization devices and cold chain equipment, and vector control products — that are prequalified and have assisted in improving public health in low- and middle-income countries (LMIC). WHO prequalification has become a trusted and reputed symbol for safety, quality and efficacy across stakeholders.

What types of product does WHO prequalify?

IVD prequalification covers a wide array of diagnostics for both endemic and epidemic diseases in LMIC.

Medicines prequalification currently covers HIV/AIDS, malaria, TB, reproductive health, hepatitis, diarrhoeal diseases and selected neglected tropical diseases. It recently intiated prequalification of biotherapeutic products: selected products to treat certain types of cancer, and human insulin for diabetes.

Vaccines prequalification covers all vaccines required for routine immunization against 24 priority diseases, while immunization devices prequalification covers all equipment needed for an effective national vaccine programme.

Vector control prequalification is the "newest" prequalification product stream, focusing on assessment of new products used for the prevention of vector-borne disease. Products assessed include bed nets, sprays and larvicides.

What difference does WHO prequalification make?

Assessment of WHO-prequalification impact has demonstrated that:

  • it has enabled a large donor-funded market size of approximately US$ 3.5 billion of quality, safe and effective IVDs, medicines and vaccines: it is likely that, in addition, prequalified IVDs, medicines and vaccines are procured by national governments, as well as private-sector organizations within country
  • helps ensure that products are developed for an LMIC context: meaning that they are appropriate for use in the populations for which they intended and are not negatively affected by the conditions of the environment in which they may be transported or stored
  • plays an important role in guiding product innovation and early-stage development: examples have included bringing paediatric TB products to market in sub-Saharan Africa and promulgating the deployment and use of HIV self-testing diagnostics
  • it has helped raised manufacturing standards in LMIC: the number of medicines and vaccines MIC manufacturers participating successfully in WHO prequalification continues to grow: meaning that capacity and confidence with respect to LMIC production of quality-assured products in those countries is likewise growing; LMIC now represent more than 40% of all manufacturers with prequalified medicines and 50% of manufacturers with prequalified vaccines.

In addition, WHO prequalification has contributed to strengthening of country health and regulatory systems. This has included work in support of WHO's development of norms and standards, its contribution to strengthening of national regulatory authorities and regulatory harmonization, and its support to building national and global capacity for safety monitoring and vigilance for health products.

The public health impact of prequalification is considerable. In 2019 it was estimated that about 400 million additional patients may have obtained access to needed health products on an annual basis thanks to generation of savings by WHO prequalification (and assuming that funding is not diverted to other causes). In other words, WHO prequalification is a sound investment. Working in collaboration with many stakeholders, in the broad ecosystem that is global health, WHO prequalification contributes to savings of approximately US$ 30–40 for every US$ 1 that is invested in it.

In addition: risk-based assessment

WHO prequalification also undertakes risk-based assessment of products during public health emergencies of international concern. This has included for the Ebola and Zika virus disease, and most recently for coronavirus disease (COVID-19). Risk-based assessment is also carried out on behalf of procurement agencies when prequalified or stringently-approved products are yet available or not availabe in sufficient quantity.