The WHO Prequalification of Medicines Programme was launched in 2001, in partnership with UNAIDS, UNICEF and the UN Population Fund, with support from the World Bank. Its focus was tackling the quality problems commonly associated with medicines for treating HIV/AIDS, malaria and tuberculosis (TB). In 2006, the Programme laid the groundwork for prequalifying medicines and commodities for reproductive health. This was in response to the fact that, in many developing countries, the need for family planning and reproductive health services remains urgent.

Evaluation of medicines by the Programme includes assessment of data and information on safety, efficacy and quality. In addition, inspections are performed to assess to assess compliance with good manufacturing practices (GMP). Inspection activities expanded in 2003 to include manufacturers of selected active pharmaceutical ingredients(API), and in 2004, to include clinical sites. Clinical sites, including contract research organizations (CROs), are inspected to verify bio-equivalence with good laboratory practices and good clinical practices.