In the fiscal year 2023, a total of *** new drugs were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, *** of which were newly applied and approved. New drugs refer to medical drugs which are clearly different from existing drugs in terms of active ingredients, ethical combination, administration, indication, dosage forms, or dosage. PMDA functions as a regulatory agency for pharmaceutical products and medical devices, working with Japan's health ministry.
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PMDA. (September 14, 2024). Number of new drugs approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023 [Graph]. In Statista. Retrieved December 19, 2025, from https://www.statista.com/statistics/1118447/japan-pmda-approved-new-medicines/
PMDA. "Number of new drugs approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023." Chart. September 14, 2024. Statista. Accessed December 19, 2025. https://www.statista.com/statistics/1118447/japan-pmda-approved-new-medicines/
PMDA. (2024). Number of new drugs approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023. Statista. Statista Inc.. Accessed: December 19, 2025. https://www.statista.com/statistics/1118447/japan-pmda-approved-new-medicines/
PMDA. "Number of New Drugs Approved by The Pharmaceuticals and Medical Devices Agency (Pmda) in Japan from Fiscal Year 2014 to 2023." Statista, Statista Inc., 14 Sep 2024, https://www.statista.com/statistics/1118447/japan-pmda-approved-new-medicines/
PMDA, Number of new drugs approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023 Statista, https://www.statista.com/statistics/1118447/japan-pmda-approved-new-medicines/ (last visited December 19, 2025)
Number of new drugs approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from fiscal year 2014 to 2023 [Graph], PMDA, September 14, 2024. [Online]. Available: https://www.statista.com/statistics/1118447/japan-pmda-approved-new-medicines/