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. 2022 Dec 3;57(3):484–514. doi: 10.1007/s43441-022-00480-3

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%