WHO prequalification programme for medicines

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Today, one third of the world’s population lacks access to essential medicines. In the poorest parts of Africa and Asia this figure rises to a half of the population.

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Every year, billions of US dollars worth of medicines are purchased by or through international procurement agencies – such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNITAID – for distribution in resource-limited countries.

The WHO Prequalification of Medicines Programme (PQP) ensures that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy.

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

The WHO PQP was launched in 2001, in partnership with UNAIDS, UNICEF and the United Nations Population Fund, with support from the World Bank. Since it was established in 2001, the PQP has prequalified over 240 medicines for priority diseases.

Its initial focus was tackling the quality problems commonly associated with medicines for treating HIV/AIDS, malaria and tuberculosis. In 2006, the PQP also laid the groundwork for prequalifying medicines and commodities for reproductive health, responding to the need for family planning in many developing countries.

In 2009, a total of 44 pharmaceutical products were prequalified by WHO, of which three were reproductive health products and 39 were generics.

In addition to enabling wider access to medicines, the project has contributed to improving standards of generic producers and helped enhance countries’ capacity to produce quality medicines.

References

Medicins Sans Frontieres (MSF). Access to medicines. MSF campaigns to challenge the high cost of existing medicines and the absence of treatment for many of the diseases affecting our patients [monograph on the Internet]. Paris, France: MSF; c2006 [cited 2010 October 5].

WHO. Prequalification of medicines by WHO. [Monigraph on the Internet]. Geneva, Switzerland: WHO; c2010 [cited 2010 October 5].

WHO. WHO Prequalification of Medicines Programme (PQP) Facts and Figures for 2009.

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