Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released a status report in October 2008 on its efforts to cut drug and device lag by 2.5 years by fiscal year (FY) 2011, which begins in April of 2011.
The PMDA has tried to decrease registration approval time by increasing the number of PMDA staff. In April 2006, there were 319 total employees, including 197 in the Review Center and 49 in the Safety Department. April 2007 saw an increase of about 6% to 341 total employees. As of April 2008, the number had increased by 25% to 426 total employees, and the number of Review Center staff increased by 71. According to the PMDA’s plans, they expect to have 484 total staff in 2009 and 582 in 2010.
The PMDA is also attempting to speed up the review process by decreasing review times for drug and medical device applications. The PMDA is trying to shorten the approval process by setting a target for application review times.
For pharmaceuticals, in FY 2006, the PMDA approved 77 new drugs with a median total review time of 21.7 months. In FY 2007, there were 81 new drugs approved with the median total review time reduced to 20.1 months.
For medical devices, in FY 2006, there were 23 new medical devices approved, with a median total review time of 19.7 months. In FY 2007, there were 26 medical devices approved, with the median total review time decreased to 17.1 months.
Despite working to shorten approval times, the PMDA has continued its commitment to quality and safety for registered medical devices and drugs. With increasing numbers of applications for medical products each year, the PMDA must inspect larger quantities of facilities and documents in a shorter amount of time.
The number of document conformity audits has increased dramatically for medical devices in recent years. In FY 2005, there was only 1 medical devices document conformity audit, but this number jumped to 175 in FY 2006 and 540 in FY 2007.
Also, the number of Good Manufacturing Practice (GMP) and Quality Management Systems (QMS) audits has increased in the past few years for pharmaceuticals, in vitro diagnostics (IVDs), quasi-drugs, and medical devices. There were 94 total medical product GMP/QMS audits in FY 2005, with 39 on-site inspections. This number increased to 1,120 in FY 2006, with 204 on-site inspections, and reached 1,998 in FY 2007 with 246 on-site inspections. Pacific Bridge Medical is currently doing mock audits to help medical manufacturers meet Japanese QMS standards before the actual audit by PMDA officials.