Japan's MHLW plans user fee hike

Japan's Ministry of Health, Labor and Welfare has proposed raising the fee for reviewing New Drug Applications starting from April 1, to efficiently conduct the approval system and to shorten the review period by reducing the workload per reviewer and increasing the number of reviewers.

Since the Pharmaceutical and Medical Device Agency started its operation in 2004, Japan's drug approval review system has been improved and the review period has been shortened. However, since it is still said that the Japanese system has generated a so-called "drug lag" behind the USA and Europe, the MHLW has decided to raise user fee to address the problem.

According to the proposal, the user fee for pharmaceuticals, including new drugs, generic copies and over-the-counter medicines will increase about 2.4-fold in principle. For instance, the fee for a new drug with a novel active ingredient, a new administration route and a new combination, a new drug with a new indication and a new dosage, will rise from 9,841,500 yen ($82,668) to 23,788,100 yen, and from 4,699,000 yen to 11,353,100 yen, respectively. The fee for an orphan drug will go up from 8,251,700 yen to 19,934,100 yen.