New active substance approvals
RecordSTO-AMV8QYAVFB-PB1H3DYFVG-JH21W6
Australia · 2025
New active substance approvals in Australia were 42 in 2025 (CIRS).
New active substance approvals: every country and year, and how it is measured
- Publisher
- CIRS
- Authority tier
- T3 Research
- Locator
- Key Findings
- Retrieved
- 17 Sep 2026
- Status
- Verified
What the source says
In 2025, FDA granted the highest number of new active substance approvals (50), followed by Health Canada (44), TGA (42), PMDA (40), EMA (39), and Swissmedic (34).
Checked: the figure 42is stated in this passage. If it does not match, the extraction is wrong and we want to know.
Cite this figure
APA
Centre for Innovation in Regulatory Science. (2025). New Drug Approvals by Six Major Authorities 2016-2025. Retrieved September 17, 2026, from https://cirsci.org/publications/cirs-rd-briefing-106-new-drug-approvals-by-six-major-authorities-2016-2025/. Via StatOrigin, https://statorigin.org/stat/stat_AMV8QYAVFBPB1H3DYFVGJH21W6
Other formats: MLA, Chicago, BibTeX
- MLA
- Centre for Innovation in Regulatory Science. "New Drug Approvals by Six Major Authorities 2016-2025." 2025, https://cirsci.org/publications/cirs-rd-briefing-106-new-drug-approvals-by-six-major-authorities-2016-2025/. Accessed 17 Sept. 2026 via StatOrigin, https://statorigin.org/stat/stat_AMV8QYAVFBPB1H3DYFVGJH21W6.
- Chicago
- Centre for Innovation in Regulatory Science. "New Drug Approvals by Six Major Authorities 2016-2025." 2025. https://cirsci.org/publications/cirs-rd-briefing-106-new-drug-approvals-by-six-major-authorities-2016-2025/. Accessed September 17, 2026. Cited from StatOrigin, https://statorigin.org/stat/stat_AMV8QYAVFBPB1H3DYFVGJH21W6.
- BibTeX
- @misc{cirs2025activejh21w6, author = {{Centre for Innovation in Regulatory Science}}, title = {New Drug Approvals by Six Major Authorities 2016-2025}, year = {2025}, howpublished = {StatOrigin, https://statorigin.org}, url = {https://statorigin.org/stat/stat_AMV8QYAVFBPB1H3DYFVGJH21W6}, note = {Original source: https://cirsci.org/publications/cirs-rd-briefing-106-new-drug-approvals-by-six-major-authorities-2016-2025/. Accessed September 17, 2026.} }
Data published under CC BY 4.0. The citation credits the original publisher and links to this permanent record.
Provenance and verification
Everything needed to check this number yourself, without taking our word for it.
Primary source
- Publisher
- Centre for Innovation in Regulatory Science · homepage ↗
- Authority tier
- Tier 3 · Research and companies
- Report
- New Drug Approvals by Six Major Authorities 2016-2025
- Type
- Press release
- Published
- —
- Locator
- Key Findings
- Retrieved
- 17 September 2026
- Link status
- Reachable (HTTP 200)
- Report licence
- See source
Verification
- Status
- Verified
- Review protocol
- Editorial review
- Checked on
- 17 September 2026
- Last revision
- 17 September 2026
- Permanent URL
- /stat/stat_AMV8QYAVFBPB1H3DYFVGJH21W6