WHO medicines prequalification primarily benefits populations requiring treatment for priority diseases, and women and girls in need of medicines to ensure their reproductive health.
But it also supports procurers, regulators, medicines quality control laboratories (QCLs), manufacturers and donors, in reaching their public health objectives.
Since its inception WHO medicines prequalification has:
- Improved public health outcomes and value for money through quality assurance of generic medicines, which has stimulated price competition and as a result enabled more medicines to be procured with the funds available so that millions more patients suffering from HIV/AIDS, tuberculosis or malaria can be treated. About 70% of WHO prequalified medicines are generic.
- Increased uptake of medicines designed specifically to meet low-income country needs including paediatric formulations for HIV/AIDS, TB and malaria, combination therapies to prevent HIV transmission from mothers to their new-borns, affordable antimalarials, and second-line medicines for drug-resistant HIV and TB.
- Strengthened regulatory capacity in low-income countries (LIC) by providing professional development and training for their national medicines regulators, and opportunities to participate in innovative regulatory initiatives.
- Developed an effective mechanism that significantly reduces registration time for prequalified finished pharmaceutical products (FPPs) that helps minimize the time it takes to get medicines to those who need them. (A similar procedure is now being piloted for medicines with stringent regulatory authority approval.)
- Improved capacity to manufacture FPPs and active pharmaceutical ingredients to international standards by providing effective feedback and guidance during prequalification evaluation, and organizing training and technical assistance. The improved capacity is applicable not only to the FPP or API that has been submitted for evaluation but to any FPP or API that the manufacturer produces.
- Increased the availability of medicines testing services through prequalification of QCLs. Prequalified QCLs now exist in every WHO geographic region and are able to work together with their national medicines regulatory authority to monitor the quality of medicines on the national market, be these manufactured locally or imported.