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      A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan

      Drug Design, Development and Therapy

      Dove Medical Press

      MHLW, PMDA, Yakugai, drug lag, vaccination policy, clinical study misconduct

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          Abstract

          The universal health care system in Japan is facing a historical turning point as a result of the increasing fiscal burden, rapidly aging society, and a decreasing population. To understand the challenges and opportunities in the Japanese pharmaceutical market, which occupies one tenth of the global share, this review highlights several issues related to the benefit-risk assessment that is unique to the modern Japanese society: 1) regulatory system for new drug development; 2) health hazards related to pharmaceuticals (“Yakugai” in Japanese); 3) drug lag; 4) problems and controversies in the vaccination policy; and 5) clinical study misconduct. The regulatory process places a significant importance on Japanese data collection regardless of data accumulation from other countries. Because Yakugai has repeatedly caused tragedies and social disputes historically, the regulatory judgments generally tend to be more prudential when safety concerns are raised for new and emerging pharmaceuticals. Such a regulatory system has caused more than several years of approval delays compared to delays in other countries. The problem of drug lag still lingers on despite several regulatory system revisions, while the solution is incompatible with the elimination of Yakugai because the lag potentially reduces the risk of unpredictable adverse events. The Japanese vaccination policy has also received a lot of criticism, and needs improvements so that the decision-making process can be more transparent and scientifically based. Additionally, repeated clinical study misconduct damaged the reputation of Japanese clinical studies with unnecessary defrayment in health insurance; therefore, the medical community must change its inappropriate relationship with the industry. The problems surrounding pharmaceuticals are related to centralized, strict drug pricing control under the universal health coverage. Although the current government attempts to facilitate innovative research and development of novel therapeutics in Japan, further reforms should be explored for patients who need new and emerging pharmaceuticals.

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          Most cited references 74

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          Regulatory review of novel therapeutics--comparison of three regulatory agencies.

          The upcoming reauthorization of the Prescription Drug User Fee Act focuses on improving the review process for new drug applications at the Food and Drug Administration (FDA). Using publicly available information from the FDA, the European Medicines Agency (EMA), and Health Canada, we compared the time for completion of the first review and the total review time for all applications involving novel therapeutic agents approved by the three regulatory agencies from 2001 through 2010 and determined the geographic area in which each novel therapeutic agent was first approved for use. There were 510 applications for novel therapeutic agents approved from 2001 through 2010--225 by the FDA, 186 by the EMA, and 99 by Health Canada; among the applications, there were 289 unique agents. The median length of time for completion of the first review was 303 days (interquartile range, 185 to 372) for applications approved by the FDA, 366 days (interquartile range, 310 to 445) for those approved by the EMA, and 352 days (interquartile range, 255 to 420) for those approved by Health Canada (P<0.001 for the comparison across the three agencies). The median total review time was also shorter at the FDA than at the EMA or Health Canada (P=0.002). Among the 289 unique novel therapeutic agents, 190 were approved in both the United States and Europe (either by the EMA or through the mutual recognition process), of which 121 (63.7%) were first approved in the United States; similarly, 154 were approved in both the United States and Canada, of which 132 (85.7%) were first approved in the United States. For novel therapeutic agents approved between 2001 and 2010, the FDA reviewed applications involving novel therapeutics more quickly, on average, than did the EMA or Health Canada, and the vast majority of these new therapeutic agents were first approved for use in the United States. (Funded by the Pew Charitable Trusts.).
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            Cost containment and quality of care in Japan: is there a trade-off?

            Japan's health indices such as life expectancy at birth are among the best in the world. However, at 8·5% the proportion of gross domestic product spent on health is 20th among Organisation for Economic Co-operation and Development countries in 2008 and half as much as that in the USA. Costs have been contained by the nationally uniform fee schedule, in which the global revision rate is set first and item-by-item revisions are then made. Although the structural and process dimensions of quality seem to be poor, the characteristics of the health-care system are primarily attributable to how physicians and hospitals have developed in the country, and not to the cost-containment policy. However, outcomes such as postsurgical mortality rates are as good as those reported for other developed countries. Japan's basic policy has been a combination of tight control of the conditions of payment, but a laissez-faire approach to how services are delivered; this combination has led to a scarcity of professional governance and accountability. In view of the structural problems facing the health-care system, the balance should be shifted towards increased freedom of payment conditions by simplification of reimbursement rules, but tightened control of service delivery by strengthening of regional health planning, both of which should be supported through public monitoring of providers' performance. Japan's experience of good health and low cost suggests that the priority in health policy should initially be improvement of access and prevention of impoverishment from health care, after which efficiency and quality of services should then be pursued. Copyright © 2011 Elsevier Ltd. All rights reserved.
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              Japan stem-cell trial stirs envy.

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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2015
                31 March 2015
                : 9
                : 1877-1888
                Affiliations
                Division of Social Communication System for Advanced Clinical Research, Institute of Medical Science, University of Tokyo, Tokyo, Japan
                Author notes
                Correspondence: Tetsuya Tanimoto, Division of Social Communication System for Advanced Clinical Research, Institute of Medical Science, University of Tokyo, 4-6-1 Shirokanedai, Minato-ku, 108-0071, Tokyo, Japan, Tel +81 3 6409 2068, Fax +81 3 6409 2069, Email tetanimot@ 123456yahoo.co.jp
                Article
                dddt-9-1877
                10.2147/DDDT.S62636
                4386774
                © 2015 Tanimoto. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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