In 2023, the median approval time of new drugs in Japan was about 5.8 months, indicating a significant decrease compared to recent years. That year, it took around 5.8 months for products in the list of standard reviews to be approved, including accelerated approval products.
Median approval time of new drugs in Japan from 2003 to 2022, by product type
(in months)
Year for New Drug Application (NDA)
All products
Priority reveiw products
Standard review products
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Approval time refers to the median of the periods from the date of submission of application for marketing approval to the date of marketing approval.
Products filed for New Drug Application (NDA) since 2016 have some pending items and are not included.
Standard review products include accelerated approval products.
Products related to "Special Approval for Emergency" are included only in the figures of "all products."
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Japan Pharmaceutical Manufacturers Association. (March 3, 2024). Median approval time of new drugs in Japan from 2003 to 2022, by product type (in months) [Graph]. In Statista. Retrieved September 17, 2024, from https://www.statista.com/statistics/1315167/japan-median-approval-time-new-drugs-by-type/
Japan Pharmaceutical Manufacturers Association. "Median approval time of new drugs in Japan from 2003 to 2022, by product type (in months)." Chart. March 3, 2024. Statista. Accessed September 17, 2024. https://www.statista.com/statistics/1315167/japan-median-approval-time-new-drugs-by-type/
Japan Pharmaceutical Manufacturers Association. (2024). Median approval time of new drugs in Japan from 2003 to 2022, by product type (in months). Statista. Statista Inc.. Accessed: September 17, 2024. https://www.statista.com/statistics/1315167/japan-median-approval-time-new-drugs-by-type/
Japan Pharmaceutical Manufacturers Association. "Median Approval Time of New Drugs in Japan from 2003 to 2022, by Product Type (in Months)." Statista, Statista Inc., 3 Mar 2024, https://www.statista.com/statistics/1315167/japan-median-approval-time-new-drugs-by-type/
Japan Pharmaceutical Manufacturers Association, Median approval time of new drugs in Japan from 2003 to 2022, by product type (in months) Statista, https://www.statista.com/statistics/1315167/japan-median-approval-time-new-drugs-by-type/ (last visited September 17, 2024)
Median approval time of new drugs in Japan from 2003 to 2022, by product type (in months) [Graph], Japan Pharmaceutical Manufacturers Association, March 3, 2024. [Online]. Available: https://www.statista.com/statistics/1315167/japan-median-approval-time-new-drugs-by-type/
