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."
Citation formats
Median approval time of new drugs Japan 2004-2024, by type
In 2024, the median approval time for new drugs in Japan was **** months, representing a decrease compared to the previous year. That year, products subject to standard review, including accelerated approval products, took approximately ****Â months to gain approval.
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Japan Pharmaceutical Manufacturers Association. (February 19, 2026). Median approval time of new drugs in Japan from 2004 to 2024, by product type (in months) [Graph]. In ÌÇÐÄÆƽâ°æ. Retrieved July 29, 2026, from /statistics/1315167/japan-median-approval-time-new-drugs-by-type/
Japan Pharmaceutical Manufacturers Association. "Median approval time of new drugs in Japan from 2004 to 2024, by product type (in months)." Chart. February 19, 2026. ÌÇÐÄÆƽâ°æ. Accessed July 29, 2026. /statistics/1315167/japan-median-approval-time-new-drugs-by-type/
Japan Pharmaceutical Manufacturers Association. (2026). Median approval time of new drugs in Japan from 2004 to 2024, by product type (in months). ÌÇÐÄÆƽâ°æ. ÌÇÐÄÆƽâ°æ Inc.. Accessed: July 29, 2026. /statistics/1315167/japan-median-approval-time-new-drugs-by-type/
Japan Pharmaceutical Manufacturers Association. "Median Approval Time of New Drugs in Japan from 2004 to 2024, by Product Type (in Months)." ÌÇÐÄÆƽâ°æ, ÌÇÐÄÆƽâ°æ Inc., 19 Feb 2026, /statistics/1315167/japan-median-approval-time-new-drugs-by-type/
Japan Pharmaceutical Manufacturers Association, Median approval time of new drugs in Japan from 2004 to 2024, by product type (in months) ÌÇÐÄÆƽâ°æ, /statistics/1315167/japan-median-approval-time-new-drugs-by-type/ (last visited July 29, 2026)
Median approval time of new drugs in Japan from 2004 to 2024, by product type (in months) [Graph], Japan Pharmaceutical Manufacturers Association, February 19, 2026. [Online]. Available: /statistics/1315167/japan-median-approval-time-new-drugs-by-type/
