C21 · Pharmaceuticals · 6 regions
Median drug approval time
Switzerland had the highest median drug approval time in 2025, at 413 days, ahead of Canada (369 days) and Australia (350 days). European Union: 448 days in 2025.
- 448 days Latest · European Union · 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.
Median drug approval time by region
Latest value per region, 2025
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
6 records · 6 regions · 2025. Each period links to its record: the value, its source evidence and original document.
| Period | Value | Source | Type |
|---|---|---|---|
| European Union 1 record | |||
| 2025 | 448 days | CIRS · 31 Dec 2025 | |
| Switzerland 1 record | |||
| 2025 | 413 days | CIRS · 31 Dec 2025 | |
| Canada 1 record | |||
| 2025 | 369 days | CIRS · 31 Dec 2025 | |
| Australia 1 record | |||
| 2025 | 350 days | CIRS · 31 Dec 2025 | |
| United States 1 record | |||
| 2025 | 322 days | CIRS · 31 Dec 2025 | |
| Japan 1 record | |||
| 2025 | 292 days | 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 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
- Median duration in days required by a regulatory authority to approve a new active substance application.
- Measure
- One slice of Drug approval time ( form: duration ) . Duration required by a regulatory authority to approve a drug marketing application. 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 approval time
Frequently asked questions
What is the latest median drug approval time?
Switzerland had the highest median drug approval time in 2025, at 413 days, ahead of Canada (369 days) and Australia (350 days). European Union: 448 days in 2025.
Which country has the highest median drug approval time?
Switzerland, at 413 days 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). Median drug approval time [Data set]. Retrieved October 28, 2026, from https://statorigin.org/indicators/median-drug-approval-time
"Median drug approval time." StatOrigin, 2026, https://statorigin.org/indicators/median-drug-approval-time. Accessed 28 Oct. 2026.
StatOrigin. "Median drug approval time." Data set, 2026. Accessed October 28, 2026. https://statorigin.org/indicators/median-drug-approval-time.
@misc{statorigin_median_drug_approval_time_2026, title = {Median drug approval time}, author = {{StatOrigin}}, year = {2026}, url = {https://statorigin.org/indicators/median-drug-approval-time}, note = {Data set. Accessed 2026-10-28} }