C21 · Pharmaceuticals · 6 regions
New active substance approvals
United States had the highest new active substance approvals in 2025, at 50, ahead of Canada (44) and Australia (42).
- 50 Latest · United States · 2025
- Annual Release cadence
- 6 Records · 6 regions · 2025
Verified 17 Sep 2026 · 1 publisher · Next period 2026
By region
Each region's latest published value. Periods differ where publishers release on different schedules; the period sits under each name.
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 record
6 records · 6 regions · 2025. Each period links to its record: the value, its source evidence and original document.
| Period | Value | Source | Type |
|---|---|---|---|
| United States 1 record | |||
| 2025 | 50 | CIRS · 31 Dec 2025 | |
| Canada 1 record | |||
| 2025 | 44 | CIRS · 31 Dec 2025 | |
| Australia 1 record | |||
| 2025 | 42 | CIRS · 31 Dec 2025 | |
| Japan 1 record | |||
| 2025 | 40 | CIRS · 31 Dec 2025 | |
| European Union 1 record | |||
| 2025 | 39 | CIRS · 31 Dec 2025 | |
| Switzerland 1 record | |||
| 2025 | 34 | CIRS · 31 Dec 2025 | |
Download this data
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Quote any number, cite this page or a single record, and link to it anywhere.
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The data is published under CC BY 4.0, commercial use included. Credit StatOrigin and the original publisher (CIRS); the chart files already carry that line.
- The source documents: the publisher's terms
Figures are facts read from the publishers' own documents. The documents themselves, their text and design, stay under each publisher's terms; follow the source links for those.
How this measure is built
- Definition
- Total count of new active substance marketing approvals granted by regulatory authorities during the period.
- Measure
- One slice of Drug approvals ( form: count, segment: new active substance ) . Total number of therapeutic drugs granted regulatory marketing approval. Region and period are columns on every record, not slices.
- Limitations
- Values are shown as published; StatOrigin does not revise, fill gaps or convert currencies.
- Verification
- Each value, unit, period and place was checked against its source evidence before publication. See the methodology and the corrections process.
Sources · 1 document
| Document | Publisher | Published | Data points |
|---|---|---|---|
| New Drug Approvals by Six Major Authorities 2016-2025 | CIRS | — | 6 |
Other slices of drug approvals
- First-in-class drug approvals 9 first in class
- Innovative drug approvals 5 innovative
- Novel drug approvals 3 novel
- Pediatric medicine approvals 3 pediatric
- Rare disease medicine approvals 3 rare disease
- Approved innovative drugs designated as breakthrough therapies 2 breakthrough therapy
- Common new active substance approvals across major regulatory authorities (multi-year total) 2 cumulative · common across authorities · new active substance
- Domestic first-in-class drug approvals 2 domestic · first in class
- Domestic innovative biological product approvals 2 domestic · innovative biologic
- Domestic innovative chemical drug approvals 2 domestic · innovative chemical
- Domestic innovative drug approvals (half year) 2 domestic · innovative
- Domestic share of approved innovative biological products 2 domestic · innovative biologic
Frequently asked questions
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. 5 countries published figures for that period.
Where does this data come from?
From 1 document published by CIRS. Every figure on this page links to its record, which preserves the original source evidence.
How often is it updated?
Annual. The newest published period is 2025; the next release should cover 2026. A new figure appears here once the publisher releases it and it passes verification.
Can I use this data?
Yes. StatOrigin publishes it under CC BY 4.0: you may copy, chart and republish it, including commercially, with attribution to StatOrigin and to the original publisher.
Cite this page
Cite the page as a data set, or open any record to cite one figure: each record carries APA, MLA, Chicago and BibTeX forms that credit the original publisher.
StatOrigin. (2026). New active substance approvals [Data set]. Retrieved October 28, 2026, from https://statorigin.org/indicators/new-active-substance-approvals
"New active substance approvals." StatOrigin, 2026, https://statorigin.org/indicators/new-active-substance-approvals. Accessed 28 Oct. 2026.
StatOrigin. "New active substance approvals." Data set, 2026. Accessed October 28, 2026. https://statorigin.org/indicators/new-active-substance-approvals.
@misc{statorigin_new_active_substance_approvals_2026, title = {New active substance approvals}, author = {{StatOrigin}}, year = {2026}, url = {https://statorigin.org/indicators/new-active-substance-approvals}, note = {Data set. Accessed 2026-10-28} }