New active substance approvals

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).

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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_84WCV23H6VE3N5JEVT5K316PE0

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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_84WCV23H6VE3N5JEVT5K316PE0.

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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_84WCV23H6VE3N5JEVT5K316PE0.

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BibTeX

@misc{cirs2025active316pe0, 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_84WCV23H6VE3N5JEVT5K316PE0}, note = {Original source: https://cirsci.org/publications/cirs-rd-briefing-106-new-drug-approvals-by-six-major-authorities-2016-2025/. Accessed September 17, 2026.} }

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Record last modified 17 September 2026. Value type: actual. Update cadence: annual. This page is permanently addressable at statorigin.org/stat/stat_84WCV23H6VE3N5JEVT5K316PE0.