Median drug approval time
Median duration in days required by a regulatory authority to approve a new active substance application.
Unit days Industry Pharmaceuticals
The chart
By region
Each region's latest published value. Periods differ where publishers release on different schedules; the period sits under each name.
Median drug approval time by region
Latest value per region, 2025
Vertical line: Mean
View the underlying data
| Category | Source | Type | Value |
|---|---|---|---|
| European Union | CIRS | Actual | 448 days |
| Switzerland | CIRS | Actual | 413 days |
| Canada | CIRS | Actual | 369 days |
| Australia | CIRS | Actual | 350 days |
| United States | CIRS | Actual | 322 days |
| Japan | CIRS | Actual | 292 days |
Every record
All records
6 records · 6 regions · 2025
| Period | Value | Source | Type |
|---|---|---|---|
| European Union 1 record | |||
| 2025 | 448 days | CIRS · 31 Dec 2025 | actual |
| Switzerland 1 record | |||
| 2025 | 413 days | CIRS · 31 Dec 2025 | actual |
| Canada 1 record | |||
| 2025 | 369 days | CIRS · 31 Dec 2025 | actual |
| Australia 1 record | |||
| 2025 | 350 days | CIRS · 31 Dec 2025 | actual |
| United States 1 record | |||
| 2025 | 322 days | CIRS · 31 Dec 2025 | actual |
| Japan 1 record | |||
| 2025 | 292 days | CIRS · 31 Dec 2025 | actual |
Primary documents
Sources
1 document. Each links to the publisher's own copy.
| Document | Publisher | Published | Data points |
|---|---|---|---|
| New Drug Approvals by Six Major Authorities 2016-2025 | CIRS | — | 6 |
Cite & reuse
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StatOrigin. (2026). Median drug approval time. Retrieved from https://statorigin.org/indicators/median-drug-approval-time