PREQUALIFICATION PROGRAMME
A United Nations Programme managed by WHO

Vision

Good quality medicines for everyone.

Mission

In close cooperation with national regulatory agencies and partner organizations, the Prequalification Programme aims to make quality priority medicines available for the benefit of those in need.

This is achieved through its evaluation and inspection activities, and by building national capacity for sustainable manufacturing and monitoring of quality medicines.

Strategy

• Apply unified standards of acceptable quality, safety and efficacy.

• Comprehensively evaluate the quality, safety and efficacy of medicinal products, based on information submitted by the manufacturers, and inspection of the corresponding manufacturing and clinical sites.

• Prequalify quality control laboratories of pharmaceuticals.

• Build the capacity of staff from national regulatory authorities, quality control laboratories, and from manufacturers or other private companies, to ensure medicines quality.

Key output

The list of prequalified medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health produced by the Programme is used principally by United Nations agencies including UNAIDS and UNICEF to guide their procurement decisions. But, the list has become a vital tool for any agency or organization involved in bulk purchasing of medicines, be this at country level, or at international level, as demonstrated by the Global Fund to Fight AIDS, Tuberculosis and Malaria.