Ranking · 5 countries · 2025
New active substance approvals by country (2025)
The United States had the highest new active substance approvals in 2025, at 50, followed by Canada (44) and Australia (42). The ranking compares 5 countries on 2025 figures from CIRS. Switzerland ranked last of the 5, at 34. For reference, the European Union stood at 39.
How this ranking is built. Indicator: New active substance approvals · Topic: New drug approvals · Industry: Pharmaceuticals · Period: 2025. Only verified actual figures for that one period are ranked, so every row is comparable; forecasts are not ranked, and world or regional totals are shown as reference, not ranked.
Visualised
Ranked chart
New active substance approvals by country
2025
European Union: 39: 39
View the underlying data
| Category | Source | Type | Value |
|---|---|---|---|
| United States | Centre for Innovation in Regulatory Science | Actual | 50 |
| Canada | Centre for Innovation in Regulatory Science | Actual | 44 |
| Australia | Centre for Innovation in Regulatory Science | Actual | 42 |
| Japan | Centre for Innovation in Regulatory Science | Actual | 40 |
| Switzerland | Centre for Innovation in Regulatory Science | Actual | 34 |
The table
Country ranking
Rank · country · value · source.
| # | Country | Value | Period | Source |
|---|---|---|---|---|
| 1 | United States US | 50 | 2025 | Centre for Innovation in Regulatory Science |
| 2 | Canada CA | 44 | 2025 | Centre for Innovation in Regulatory Science |
| 3 | Australia AU | 42 | 2025 | Centre for Innovation in Regulatory Science |
| 4 | Japan JP | 40 | 2025 | Centre for Innovation in Regulatory Science |
| 5 | Switzerland CH | 34 | 2025 | Centre for Innovation in Regulatory Science |
| — | European Union Reference total, not ranked | 39 | 2025 | Centre for Innovation in Regulatory Science |
Frequently asked questions
Which country has the highest new active substance approvals?
The United States, at 50 in 2025, ahead of Canada (44) and Australia (42), among 5 countries ranked on 2025 figures from CIRS.
Which country has the lowest new active substance approvals?
Switzerland, at 34 in 2025, then Japan (40).
What does this ranking measure?
Total count of new active substance marketing approvals granted by regulatory authorities during the period.
Which countries are included?
5 countries with 2025 figures: United States, Canada, Australia, Japan and Switzerland.
Where does the data come from?
From CIRS. Every value links to its record, which quotes the table or sentence it was read from. Only actual figures are ranked; forecasts are left out.
Cite & reuse
Cite this ranking
Published under CC BY 4.0.
StatOrigin. (2026). New active substance approvals by country, 2025. Retrieved from https://statorigin.org/rankings/new-active-substance-approvals-by-country