Table 4.
Pilot study summary results: The summary results of the backlog Phase 1 pilot projects conducted by SAHPRA in 2016 and 2021
| 2016 risk-based approach in P&A Pre-Reg Unit | 2021 risk-based approach in Backlog Clearance Program | |
|---|---|---|
| Time received to time when application was allocated | 1,542 calendar days | 431 calendar days |
| Product total (master applications) | 150 | 63 (RW 8) |
| Withdrawn (opted out) | 51 | 6 |
| Product used in the pilot project | 99 | 57 |
| Number of evaluators used | 10 | 10 |
| Evaluation week (products evaluated) | 54 | Weekly meetings for 10 weeks |
| Finalisation time (median) | 90 calendar days (3 months) | 68 calendar days (2.3 months) |
| Approval timea (median) | 109 calendar days | 110 calendar days |
P&A Pre-Reg Pharmaceutical and Analytical Pre-Registration
aThe approval time is calculated from date of initial allocation