Human medicines recommended for marketing authorization with new active substance

Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before.

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APA

European Medicines Agency. (2025). EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines. Retrieved September 17, 2026, from https://www.ema.europa.eu/en/news/emas-2025-annual-report-shows-strong-approval-numbers-human-veterinary-medicines. Via StatOrigin, https://statorigin.org/stat/stat_N6X2GMB3Q4Y7Q9FAVAD19T8Z83

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MLA

European Medicines Agency. "EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines." 2025, https://www.ema.europa.eu/en/news/emas-2025-annual-report-shows-strong-approval-numbers-human-veterinary-medicines. Accessed 17 Sept. 2026 via StatOrigin, https://statorigin.org/stat/stat_N6X2GMB3Q4Y7Q9FAVAD19T8Z83.

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Chicago

European Medicines Agency. "EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines." 2025. https://www.ema.europa.eu/en/news/emas-2025-annual-report-shows-strong-approval-numbers-human-veterinary-medicines. Accessed September 17, 2026. Cited from StatOrigin, https://statorigin.org/stat/stat_N6X2GMB3Q4Y7Q9FAVAD19T8Z83.

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BibTeX

@misc{ema2025human9t8z83, author = {{European Medicines Agency}}, title = {EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines}, year = {2025}, howpublished = {StatOrigin, https://statorigin.org}, url = {https://statorigin.org/stat/stat_N6X2GMB3Q4Y7Q9FAVAD19T8Z83}, note = {Original source: https://www.ema.europa.eu/en/news/emas-2025-annual-report-shows-strong-approval-numbers-human-veterinary-medicines. 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_N6X2GMB3Q4Y7Q9FAVAD19T8Z83.