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Registration timelines of antiretroviral medicines in Ghana and Kenya.
AIDS 2020 Februrary 18
: This study examines registration timelines of antiretroviral medicines (ARVs) in Ghana and Kenya, to assess whether prior reviews by the US Food and Drug Administration Tentative Approval or World Health Organization prequalification (WHO/PQP) affect in-country approval timelines.Data were collected from online and national databases. Median in-country review period in Ghana was nine months compared to 25 in Kenya. ARVs with Tentative Approval and WHO/PQP status did not benefit from shorter in-country review periods.
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