By essentially putting medical devices and drugs in the same regulatory bucket, Japan’s current Pharmaceutical Affairs Law (PAL) creates unnecessary restrictions and hinders the development of innovative medical technology, Kazuo Ogino, Chairman of the Japan Federation of Medical Device Associations (JFMDA) said at a press conference in Tokyo on 25 March. The industry group will actively lobby for a more medical device–oriented approval system under the PAL, he added.
Japan’s Health, Labour and Welfare Ministry plans to revise the PAL in the next fiscal year, which begins in April 2012. Much of the ministry’s emphasis, however, is on the prevention of drug-induced diseases, so JFMDA will focus on convincing the ministry that drugs and medical devices are very different products. The association will lobby for an accelerated approval system, especially for previously approved devices that have received upgrades. Currently, these devices need to go through the approval process again.
“The association has already established a consensus among its 20 member associations. We are now looking for the right time to file our petitions with the ministry,” Ogino said at the press conference.Miki Anzai