Drug type | WHO QA programme*† | Global Fund QA standard* | USFDA‡ | ||||
PQP | USFDA | SRA only | WHO/PQP and SRA | WHO/PQP only | ERP | PEPFAR process | |
Single drug | 72 | 57 | 65 | 53 | 37 | 0 | 131 |
2 Drugs FDC | 34 | 26 | 28 | 22 | 14 | 1 | 51 |
3 Drugs FDC | 20 | 13 | 12 | 15 | 7 | 0 | 28 |
Copackaged | 2 | 10 | 11 | 1 | 4 | 0 | 14 |
Total | 128 | 106 | 116 | 91 | 62 | 1 | 224 |
Grand total | 234 | 270 | 224 |
*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†Includes products no longer active with the USFDA, which were excluded in subsequent matching analyses.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.