Median drug approval time

PMDA recorded the shortest median approval time in 2025 (292 days), followed by FDA (322 days), TGA (350 days), Health Canada (369 days), Swissmedic (413 days) and EMA (448 days).

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Published under CC BY 4.0. Attribute the original publisher; the citations below do that for you and link to this permanent record.

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_B1EWGR1ZAMXV2PVS7F6YTM8M93

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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_B1EWGR1ZAMXV2PVS7F6YTM8M93.

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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_B1EWGR1ZAMXV2PVS7F6YTM8M93.

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BibTeX

@misc{cirs2025mediantm8m93, 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_B1EWGR1ZAMXV2PVS7F6YTM8M93}, 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_B1EWGR1ZAMXV2PVS7F6YTM8M93.