Table 5.
Time gain when using expedited versus standard review pathways for new active substance approvals, complemented and adapted from CIRS [15]
Jurisdiction | Median Approval Timea in days (based on overall approval time) | Percentage time saved with expedited reviewb | ||
---|---|---|---|---|
Expedited | Standard | Benefit (reduction in days) | ||
Australia (TGA) | 221 | 354 | 133 | 38% |
Canada (Health Canada) | 207 | 343 | 136 | 40% |
EU (EMA/CHMP) | 250 | 434 | 184 | 42% |
Japan (PMDA) | 266 | 331 | 108 | 43% |
Switzerland (SwissMedic) | 245 | 399 | 154 | 33% |
US (FDA) | 242 | 365 | 123 | 34% |
EMA = European Medicines Agency; FDA = US Food and Drug Administration; PMDA = Japan Pharmaceuticals and Medical Devices Agency, TGA = Australian Therapeutic Goods Administration
aCalculated from day of submission to date of approval by agency. Includes EU Commission time for EU
bCalculated as reduction in days/standard review time in days × 100%