Support for WHO prequalification of diagnostics and medicines

Increasing access and scale-up of quality-assured health products.


Lack of affordable, adapted, quality-assured health products for use in low- and middle-income countries delays progress towards global health targets.


WHO prequalification is a cross-cutting intervention that is effectively and comprehensively addressing shortcomings in manufacture, regulation and supply of priority diagnostics and medicines across multiple diseases or product types. It serves as a single entry point to donor funding for manufacturers willing to offer quality products. It is a key mechanism for enabling Unitaid to meet its strategic objectives.

“Unitaid values WHO prequalification because it addresses a significant public health need – access to critical, quality-assured health products in low- and middle-income countries – by alleviating market failures such as lack of quality, affordability, or programmatic suitability of needed products”

Kate Hencher, Programme Manager, Unitaid

Results so far

Since Unitaid started to support WHO prequalification, more than 200 medicines and over 60 diagnostics have been prequalified for HIV/AIDS, hepatitis C, tuberculosis and malaria. The program has also generated tangible benefits to public health in low- and middle-income countries through

  • facilitating capacity building and collaboration between regulators,
  • accelerating access to urgently-needed medical products through the collaborative procedure for national registration; and
  • contributing to market sustainability and lower prices by increasing fair competition among quality products.

The WHO prequalification programme was created with a view to ensuring that products selected and procured by the United Nations (UN) were of assured quality and efficacy. As support from the international community intensified, the programme quickly became a reference point for procurement beyond the UN (as demonstrated by the Global Fund). Today, the programme is widely recognized for having made an enormous contribution in terms of accelerating and increasing access to critical quality-assured products that are affordable and adapted for markets in low- and middle-income countries.


Unitaid supports the Expert Review Panel mechanism which responds to the need to accelerate market entry of new and innovative medicines and diagnostics through a risk-based approach to time-limited procurement of specific products. The review focuses on products of high public-health impact that are a priority for the Global Fund and Unitaid and yet to undergo stringent regulatory assessment.

For more information about this mechanism, and all the latest updates (invitations for expression of interest), please refer to the Global Fund website

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