Japan's MHLW to "speed up" Rx drug approvals

Japan's Ministry of Health, Labor and Welfare has announced a package of measures aimed at reducing "drug lag," the delay between the approval of a medicine in foreign countries and in Japan. The Nikkei Weekly reports that the Ministry recognizes as unacceptable, the time scale for marketing clearance: new products take an average of four years to complete the process in Japan, versus 30 months in France and only 18 months in the USA or the UK.

Yasuo Urata, chief executive of Oncolys Biopharma, told Nikkei Weekly that "the hurdles are too high in Japan for a small venture to clear." He also contrasted the speed and efficiency of the US Food and Drug Administration's procedures compared with Japan's cumbersome bureaucracy.

The MHLW aims to cut the review process to an average of 18 months by 2011. To achieve this target, it will increase review staff by 30% to 190 and raise by 50% the frequency of meetings between applicant firms and the Ministry's Council on Drugs and Food Sanitation.