Registration timelines of antiretroviral medicines in Ghana and Kenya

AIDS. 2020 Jun 1;34(7):1093-1095. doi: 10.1097/QAD.0000000000002514.

Abstract

: 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 WHO prequalification (WHO/PQP) affect in-country approval timelines. Data were collected from online and national databases. Median in-country review period in Ghana was 9 months compared with 25 months in Kenya. ARVs with Tentative Approval and WHO/PQP status did not benefit from shorter in-country review periods.

MeSH terms

  • Anti-Retroviral Agents / supply & distribution*
  • Anti-Retroviral Agents / therapeutic use
  • Antiretroviral Therapy, Highly Active*
  • Drug Approval*
  • Ghana
  • HIV Infections / drug therapy*
  • Humans
  • Kenya

Substances

  • Anti-Retroviral Agents