Table 1

Total number of ARVs registered or listed by WHO/PQP, Global Fund and the USFDA, by quality assurance programme and drug type

Drug typeWHO QA programme*†Global Fund QA standard*USFDA‡
PQPUSFDASRA onlyWHO/PQP and SRAWHO/PQP onlyERPPEPFAR process
Single drug72576553370131
2 Drugs FDC3426282214151
3 Drugs FDC201312157028
Copackaged2101114014
Total12810611691621224
Grand total234270224
  • *Only products from manufacturers who have also submitted applications to the USFDA for the PEPFAR process were included in this study.

  • †Includes products no longer active with the USFDA, which were excluded in subsequent matching analyses.

  • ‡Only includes products that were in active regulatory status with the USFDA on 20 March 2017. One additional product from analysis was excluded due to inconsistencies in the USFDA database listing.

  • ERP, expert review panel; FDC, fixed drug combination; PEPFAR, US President’s Emergency Plan for AIDS Relief; PQP, Prequalification of Medicines Programme; QA, quality assurance; SRA, stringent regulatory authority; USFDA, US Food and Drug Administration.