加纳和肯尼亚抗逆转录病毒药物的注册时间轴。

Registration timelines of antiretroviral medicines in Ghana and Kenya.

机构信息

Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, USA.

School of Public Health, Faculty of Community Health Sciences, University of the Western Cape, Cape Town, South Africa.

出版信息

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

DOI:10.1097/QAD.0000000000002514

PMID:32073445

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.

摘要

本研究考察了加纳和肯尼亚抗逆转录病毒药物（ARV）的注册时间线，以评估美国食品和药物管理局（FDA）暂定批准或世界卫生组织（WHO）预认证（WHO/PQP）的预先审查是否会影响国内的审批时间线。数据来自在线数据库和国家数据库。加纳国内审查的中位时间为 9 个月，而肯尼亚为 25 个月。具有暂定批准和 WHO/PQP 地位的 ARV 并没有从较短的国内审查周期中受益。