Debate over Japan

The way to enhance the function of Japan's Pharmaceutical and Medical Device Agency and the promotion of international joint clinical trials have been discussed at the fifth meeting of a study committee on speeding up the provision of new safe and effective drugs within Japan's Ministry of Health and Welfare.

The PMDA has decided to increase the number of reviewers to 236 from the current 200 by the end of fiscal 2009 and the number of consultations, including those preceding new drug applications from 280 to 420 by the end of fiscal 2008. In addition, the PMDA will introduce a reviewers' training program based on that of the US Food and Drug Administration in order to improve their quality.

Some PDMA panel members proposed that expert and veteran staff could be recruited from private drug manufacturers and research institutes as reviewers. This would mean alleviating restrictions which prevent the PMDA from hiring people who have worked in the private sector for at least two years if they were engaged in the same field.