Japan: median approval time of new drugs by type

In 2022, 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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Release date

March 2023

More information

Region

Japan

Survey time period

2003 to 2022

Special properties

products that were approved from 2003 to 2022

Supplementary notes

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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