Business Intelligence on Biologic and Small Molecule Drugs
Figure 1 USFDA registrations of ARVs for PEPFAR
Figure 1: High‐level overview of how the USFDA registrations of ARVs for PEPFAR are used by global actors. The figure shows how USFDA registrations for PEPFAR both directly and indirectly support procurement of ARVs by various global actors. The process starts when USFDA receives a product application for review under the tFDA process (blue box). If the product meets USFDA standards for safety, efficacy and quality, it is added to the list of quality‐assured ARVs that can be purchased utilizing the United States’ PEPFAR funds by USAID and its partners (green box). In addition, the WHO selectively places some of the USFDA registered ARVs on its quality‐assured prequalification of medicines list (orange box). ARVs on the United States tFDA list and/or the WHO list may be procured by various international agencies (e.g. the Global Fund, UNICEF, UNAIDS, UNITAID) that purchase medicines for HIV treatment programmes (purple boxes). In addition to USFDA, The Global Fund, WHO, and United Nations entities may rely on other stringent regulatory authorities for quality assurance and the Global Fund may, in limited circumstances, use WHO's Expert Review Panel (grey boxes). USFDA, US Food and Drug Administration; PEPFAR, President's Emergency Plan for AIDS Relief; ARV, antiretroviral; USAID, US Agency for International Development; WHO, World Health Organization.
Figure 1: High‐level overview of how the USFDA registrations of ARVs for PEPFAR are used by global actors. The figure shows how USFDA registrations for PEPFAR both directly and indirectly support procurement of ARVs by various global actors. The process starts when USFDA receives a product application for review under the tFDA process (blue box). If the product meets USFDA standards for safety, efficacy and quality, it is added to the list of quality‐assured ARVs that can be purchased utilizing the United States’ PEPFAR funds by USAID and its partners (green box). In addition, the WHO selectively places some of the USFDA registered ARVs on its quality‐assured prequalification of medicines list (orange box). ARVs on the United States tFDA list and/or the WHO list may be procured by various international agencies (e.g. the Global Fund, UNICEF, UNAIDS, UNITAID) that purchase medicines for HIV treatment programmes (purple boxes). In addition to USFDA, The Global Fund, WHO, and United Nations entities may rely on other stringent regulatory authorities for quality assurance and the Global Fund may, in limited circumstances, use WHO's Expert Review Panel (grey boxes). USFDA, US Food and Drug Administration; PEPFAR, President's Emergency Plan for AIDS Relief; ARV, antiretroviral; USAID, US Agency for International Development; WHO, World Health Organization.