Japan’s regulatory authority, Pharmaceuticals and Medical Devices Agency (PMDA), is launching several new initiatives in fiscal year 2009, which begins today. PMDA representatives were out in force at the DIA EuroMeeting in Berlin last week to explain the new programs, which will be implemented between fiscal year 2009 and fiscal year 2013.
PMDA’s goals for the next five years include continuing to try to eliminate drug lag and further increase Japan’s participation in global clinical trials. The agency’s previous initiatives have already met with great success in terms of investigator participation in global clinical trials, which increased six-fold between 2006 and 2007.
One of the most exciting new programs that will kick off in the next five years is PMDA’s pilot program, “NDA Pre-review Consultation,” which is a scientific consultation available to sponsors before select NDA submissions.
The NDA Pre-review Consultation will occur during phase III and focus on the review of all available data from preclinical and clinical studies at that time. PMDA will provide a review report six months after the sponsor’s application is submitted. The purpose of the NDA Pre-review consultation is to allow PMDA to evaluate data before a formal NDA submission, which PMDA believes will “shorten NDA review time, identify major discussion points and tasks for NDA submission and help sponsors to prepare a good CTD [Common Technical Document].”
The process should take six months if it goes according to plan, starting with the application, followed two weeks later by the document submission. Two months after that, PMDA will make an inquiry, to which sponsors must respond within six weeks. Six weeks later, PMDA will write a draft report, on which sponsors will comment and have a face-to-face meeting with PMDA, if necessary. The final report will be written two weeks after the draft report.
The pilot program is clearly going to start small, and PMDA is still discussing what criteria it will use to determine the types of drugs that qualify for the new process. The agency “must prioritize which products are covered by consultation,” said Yoshiaki Uyama, Ph.D., review director, Office of New Drug III, PMDA. Uyama added that the program could be expanded after 2009.
PMDA also will implement the Joint Graduate School Program starting in FY09, according to Tatsuya Kondo, M.D., Ph.D., chief executive, PMDA. This program will accept medical graduate students as reviewers of new drug/device applications so that they can work on a thesis for an academic degree.
Those enrolled in the program will study case studies of recent clinical data packages (new drug reviews), participate in international conferences and major clinical academic meetings and have discussions with global pharma companies. PMDA plans to begin accepting students from other fields, such as pharmaceutical science, in the future.
The purpose of the program is to create a pool of core personnel qualified to head up the clinical research department at every medical institution in Japan.
PMDA also plans to improve and strengthen its international relations through its PMDA International Strategic Plan. The agency wants to strengthen cooperation and build cooperative relations with the EU, U.S. and other Asian countries, as well as relevant international organizations. It also wants to participate in international harmonization activities.
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