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    Japan’s PMDA, Like FDA, Seeks to Raise Scientific Training of Drug Reviewers; Forge Better Connections with Research and Academi

    June 25, 2007
    Improving innovation in drug development is a key part of "Innovation 25," the Japanese government's new plan to stimulate innovation-based growth.  However, the pharmaceutical and medical devices industries in Japan are still far more closed than they are in the U.S. or Europe.  Clinical trials are also handled quite differently. As a result, it can take years for medicines or devices approved in the U.S. or Europe to reach Japanese consumers.  Meanwhile, global pharma companies must wait much longer for new approvals than they would at home, according to a recent report by the International Trade Commission. The report found that a new device took an average of 1,083 days to approve in Japan, compared with 356 days in Japan.  The number of new device applications from U.S. companies has dropped from 132 in 2003 to eight in 2005, according to an excellent update by Yoshio Mitsumori in Medical Products Outsourcing (click here to read). To open up the regulatory process, Japan's FDA equivalent, the PMDA is planning to hire 240 more drug reviewers over the next three years, and to bring average approval times in line with global figures.  Already the Agency's New Drug Application backlog has shrunken from 139 three years ago, to 20 in March of 2007. The Agency and MHLW wants 80% of all new drugs reviewed within one year. A five-year plan launched last year aims to streamline clinical trials in Japan, and to reduce preliminary review and application review by a total of two and a half years by 2011, and to reduce by one third the wait for consultation by March 2009. But Akira Miyajima, head of PDMA, is also interested in broadening reviewers' understanding of the regulatory process, and to broaden their training in the basic science and research that will support new therapies.  This goal is very similar to goals expressed this year by FDA's Chief Medical Officer (CMO) Janet Woodcock. Mr. Miyajima spoke at a recent seminar in Tokyo sponsored by the Regulatory Affairs Professionals Society (RAPS), which focused on the importance of the regulatory affairs profession to the development of new drugs and advanced medical technology.  In attendance were over 200 high-level officials from Japan's PMDA, MHLW and other government agencies, as well as industry and academia, who agreed that Japan was still lagging other developed countries in the way it simulates innovation, explained Sherry Keramidas, Executive Director of RAPS. They agreed that harnessing R&D will be critical.  At the same time, Ms. Keramidas says, Japanese regulatory bodies and companies are beginning to  recognize regulatory affairs as a critical profession that must be involved throughout any drug product life cycle. All presentations from the seminar were in Japanese, complicating reporting on this issue, but we will bring updates on our magazine and web site as they become available. -AMS
    Improving innovation in drug development is a key part of "Innovation 25," the Japanese government's new plan to stimulate innovation-based growth.  However, the pharmaceutical and medical devices industries in Japan are still far more closed than they are in the U.S. or Europe.  Clinical trials are also handled quite differently. As a result, it can take years for medicines or devices approved in the U.S. or Europe to reach Japanese consumers.  Meanwhile, global pharma companies must wait much longer for new approvals than they would at home, according to a recent report by the International Trade Commission. The report found that a new device took an average of 1,083 days to approve in Japan, compared with 356 days in Japan.  The number of new device applications from U.S. companies has dropped from 132 in 2003 to eight in 2005, according to an excellent update by Yoshio Mitsumori in Medical Products Outsourcing (click here to read). To open up the regulatory process, Japan's FDA equivalent, the PMDA is planning to hire 240 more drug reviewers over the next three years, and to bring average approval times in line with global figures.  Already the Agency's New Drug Application backlog has shrunken from 139 three years ago, to 20 in March of 2007. The Agency and MHLW wants 80% of all new drugs reviewed within one year. A five-year plan launched last year aims to streamline clinical trials in Japan, and to reduce preliminary review and application review by a total of two and a half years by 2011, and to reduce by one third the wait for consultation by March 2009. But Akira Miyajima, head of PDMA, is also interested in broadening reviewers' understanding of the regulatory process, and to broaden their training in the basic science and research that will support new therapies.  This goal is very similar to goals expressed this year by FDA's Chief Medical Officer (CMO) Janet Woodcock. Mr. Miyajima spoke at a recent seminar in Tokyo sponsored by the Regulatory Affairs Professionals Society (RAPS), which focused on the importance of the regulatory affairs profession to the development of new drugs and advanced medical technology.  In attendance were over 200 high-level officials from Japan's PMDA, MHLW and other government agencies, as well as industry and academia, who agreed that Japan was still lagging other developed countries in the way it simulates innovation, explained Sherry Keramidas, Executive Director of RAPS. They agreed that harnessing R&D will be critical.  At the same time, Ms. Keramidas says, Japanese regulatory bodies and companies are beginning to  recognize regulatory affairs as a critical profession that must be involved throughout any drug product life cycle. All presentations from the seminar were in Japanese, complicating reporting on this issue, but we will bring updates on our magazine and web site as they become available. -AMS
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