Registration and Quality Assurance of ARVs & Other Essential Medicines in Namibia. October 2014 - September 2015
(2015; 21 pages)

Mbaziira. N. (2015). Registration and Quality Assurance of ARVs & other essential medicines in Namibia. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, Arlington, VA: Management Sciences for Health.


In FY15, SIAPS continued to provide TA to facilitate the expedited assessment and registration of new and other ARV formulations to support the implementation of the revised Namibian ART guidelines (dated January 2014). The TA targeted improving the efficiency of the regulatory system so that the recommend new first-line fixed-dose combination (FDC) ARVs that contain tenofovir and emtricitabine for adults; and optimized ARV formulations for pediatric use, other medicines for HIV and AIDS, TB, maternal newborn and child health (MNCH), and other public health diseases are assessed and considered for registration and made available for public procurement in a timely manner to the benefit of patients on the ART program.

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