[WHO program for prequalification of antiretroviral, antimalarial and antituberculosis drugs].

Abstract

Partnered with UNICEF, UNAIDS and the UN Population Fund, and receiving support from the World Bank, the WHO Prequalification Programme provides a solid, scientific assessment of the quality of both generic and patented medicines, based on internationally harmonized standards for evaluating information on product quality and bioequivalence, inspecting manufacturing sites, and undertaking quality control of pharmaceutical production. Agencies and organizations who procure medicines can be assured that products prequalified by WHO are of proven quality and that they do not themselves have to test these products. The WHO list of prequalified products also means that agencies procuring medicines can choose between several manufacturers offering the same quality product, which offers scope for negotiating lower prices. As a result of this Programme, capacity to manufacture generic products of assured quality is increasing, as is capacity to monitor that quality. Initially focusing on medicines for HIV/AIDS, TB and malaria, the Programme is now being expanded to also cover medicines for reproductive health.