Prequalification
Support for prequalification of medicines and diagnostics

Since its establishment, UNITAID has supported the WHO Prequalification Programme as an investment in the improvement of quality medicines and diagnostics globally. In 2008, UNITAID allocated a further $40 million to the programme to cover four years. The funds will be used for the prequalification of UNITAID-funded medicines, field sampling and quality testing of products supplied to users and capacity building at country level.

By January 2009, WHO had prequalified 164 HIV related medicines, 18 TB medicines and 14 malaria medicines. A further 126 products were being evaluated.

Support for WHO Prequalification will strengthen the programme’s ability to process rapidly pharmaceutical company applications for the prequalification of potentially more effective new medicines against HIV/AIDS (paediatric and second-line), malaria (ACTs) and tuberculosis (first-line and MDR-TB). The funding will also support testing and sampling of these medicines.

International laboratories will conduct sampling and analysis to determine the quality of the medicines provided to beneficiary countries through UNITAID funding. Testing and sampling is conducted with national regulatory authorities but involves the participation of some local laboratories in order to help develop local capacity in this area. It is expected that, in the short term, some national quality control laboratories will themselves be able to implement sampling and testing activities that are currently organized by the WHO Prequalification Programme.

See UNITAID-funded projects for Quality Assurance of Medicines

See UNITAID-funded projects for Quality Assurance of Diagnostics



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