C21 · Pharmaceuticals · 58 measures · 8 regions
New drug approvals
United States had the highest new active substance approvals in 2025, at 50, ahead of Canada (44) and Australia (42).
- 50 New active substance approvals · United States · 2025
- 58Measures
- 6Countries · 2016–2026
Verified 27 Sep 2026 · 8 publishers · 96 records · Next period 2026
New active substance approvals
The best-covered measure of new drug approvals. Every point opens its record; the values are one click away under the chart.
New active substance approvals by region
Latest value per region, 2025
View the underlying data
| Category | Source | Type | Value |
|---|---|---|---|
| United States | CIRS | Actual | 50 |
| Canada | CIRS | Actual | 44 |
| Australia | CIRS | Actual | 42 |
| Japan | CIRS | Actual | 40 |
| European Union | CIRS | Actual | 39 |
| Switzerland | CIRS | Actual | 34 |
Every measure of new drug approvals
58 measures: the same subject cut by product, segment, basis or form. Each has its own page with every record.
New drug approvals by country
Countries ranked on one comparable period:
A page for every country with at least three records:
Frequently asked questions
What does new drug approvals measure?
Total number of therapeutic drugs granted regulatory marketing approval.
What is the latest new active substance approvals?
United States had the highest new active substance approvals in 2025, at 50, ahead of Canada (44) and Australia (42).
Which country has the highest new active substance approvals?
United States, at 50 in 2025, among 5 countries that published that period.
Which countries does this new drug approvals data cover?
6 countries, with a page each for China, United States.
Where does the data come from?
From 18 documents published by DIA, NHSA, State Council and 5 more. Every figure links to its record, which quotes the sentence or table row it was read from.
How often is it updated?
Annual; the newest figure covers 2025, and the next release should cover 2026.
Sources
18 documents from 8 publishers. Each links to the publisher's own copy.
Cite this page
Published under CC BY 4.0: free to reuse, including commercially, with attribution to StatOrigin and the original publisher. To cite one figure, open its record.
StatOrigin. (2026). New drug approvals statistics [Data set]. Retrieved September 29, 2026, from https://statorigin.org/statistics/new-drug-approvals
"New drug approvals statistics." StatOrigin, 2026, https://statorigin.org/statistics/new-drug-approvals. Accessed 29 Sep. 2026.
StatOrigin. "New drug approvals statistics." Data set, 2026. Accessed September 29, 2026. https://statorigin.org/statistics/new-drug-approvals.
@misc{statorigin_new_drug_approvals_2026, title = {New drug approvals statistics}, author = {{StatOrigin}}, year = {2026}, url = {https://statorigin.org/statistics/new-drug-approvals}, note = {Data set. Accessed 2026-09-29} }