Prequalification

In order to assist in the procurement of quality commodities several organisations employ a prequalification system for pharmaceutical and other products. The WHO Prequalification Programme was established in 2001 as a service to facilitate access to medicines that meet unified standards of quality, safety and efficacy particularly for reproductive health drugs and those to treat malaria and tuberculosis. From the outset, the Programme was supported by UNAIDS, UNICEF, UNFPA and the World Bank as a concrete contribution to the United Nations priority goal of addressing widespread diseases in countries with limited access to quality medicines. Prequalification was originally intended to give United Nations procurement agencies, such as UNICEF the choice of a range of quality medicines. With time, the growing list of products that have been found to meet the set requirements has come to be a useful tool for anyone bulk purchasing medicines, including countries themselves and other organizations. A manufacturer wishing their medicines to be included in the prequalified product list is invited to provide extensive information on the product (or products) submitted to allow qualified assessment teams to evaluate its quality, safety and efficacy. WHO co-ordinates their list with certain other regulatory agencies including the US Federal Drug Administration (USFDA) and the European Medicines Agency (EMEA)