Possible Setback for Approval Period Reductions in Japan

Registering a medical product in Japan, from initial application to final approval, is known to be a very lengthy process, and could potentially become even more drawn out due to growing conflict over personnel issues at the PMDA. Many argue that one reason for long approval periods is a shortage of reviewers at the PMDA, and that reducing the approval period is impossible without increasing the number of reviewers. As of April 2006, there were 89 new drug reviewers (up from 78 the previous year), and only 28 medical device reviewers. The PMDA’s medium-term plan calls for at most 27 more total staff by 2009; only some of those new staff would actually be reviewers. At the same time, the Japanese government’s administrative reform goals call for a 5% across-the-board staff reduction by the end of the year, threatening the size of the already meager staff of PMDA reviewers.

To oppose this, the Japan Pharmaceutical Manufacturer’s Association (JPMA) petitioned to the Regulatory Reform and Privatization Promotion Council in July to exclude the PMDA from its personnel reduction plans. It also requested that the number of approval review staff and clinical trial consultants be permitted to double in the short term, suggesting that this increase would not strain the national budget if industry fees were increased.

In addition, current employment rules prohibit anyone who worked in medical development in the past 5 years from being hired as a reviewer. The petition argues that this restriction hinders the PMDA from hiring the most qualified people to be reviewers, and calls for it to be abolished. The JPMA president, Dr. Aoki Hatsuo, said he believes this change would not lead to government-industry collusion, because there would still be the threat of harsh penalties.