Major hike in Japan drug review fees take effect April 1

Japanese authorities are expected to increase fees in April on mandatory reviews of most categories of new drugs and medical devices. An ordinance drafted by the Ministry of Health, Labor and Welfare (MHLW) proposed increases in fees of up to 28% to review applications for pharmaceuticals, medical devices and regenerative medicine products. The new fees, which have not been finalized, are expected to come into effect on April 1.

While not all drugs and devices would be subject to the same fee hike, the proposed increases are significant. For example, review fees for new active pharmaceutical ingredients and combination drugs would rise to more than 30 million yen for orphan drugs and more than 36 million yen for all other drugs. Those are hikes of about 7 million and 8 million yen, respectively.

At manufacturing sites, fees for primary inspections of good manufacturing practices would rise by 22% in most categories, while rates of increase for periodic inspections would vary from 16% for “basic” inspections to 21% for “product-by-product” inspections.