<b>Proposal for the Best Pharmacovigilance Plan in Japan by comparing Japan Postmarketing Studies to the U.S. Postmarketing Requirements: </b>

DOI
  • KOKAN Akira
    Global Patient Safety Japan, Eli Lilly Japan K.K.
  • KAI Yasuhiko
    Post-Marketing Study Team, Santen Pharmaceutical Co., Ltd.
  • KAGEYAMA Shigeru
    Division of Clinical Pharmacology and Therapeutics, The Jikei University School of Medicine
  • KUBOTA Kiyoshi
    Department of Pharmacoepidemiology, Faculity of Medicine, University of Tokyo,
  • TSUTANI Kiichiro
    Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo
  • NISHI Toshimichi
    Drug Safety Department, Ohara Pharmaceutical Co., Ltd.
  • MAEDA Rei
    Pharmaceutical Research and Manufacturers of Amerika
  • MASADA Mikio
    Department of Pharmacy, University of Fukui Hospital
  • MIYAKAWA Kou
    Pharmacovigilance Department, Takeda Pharmaceutical Co., Ltd.

Bibliographic Information

Other Title
  • <b>米国におけるPostmarketing Requirementsと日本における市販後の研究に関する比較と提言</b>
  • <b>The Final Report from the Task Force </b>
  • <b>―米国と日本の市販後研究の比較と日本の安全性監視計画への提言に関するタスクフォースからの最終報告―</b>

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Objective: To propose the best pharmacovigilance plan in Japan by comparing post marketing safety studies in Japan and the U.S.<br>Method: Among all of the newly approved medicines in Japan in 2010, 12 marketed products in the U. S. are selected. First, to examine the U. S. system, post-marketing safety concerns over those drugs at the time of approval in the U. S. were collected as well as its postmarketing requirements (PMR) which are studies or clinical trials that sponsors are required to conduct under one or more statutes of regulations. Then, the same drugsʼ safety issues discussed as special cautions listed during the approval process in Japan and the corresponding postmarketing safety studies were reviewed.<br>Result: Both countries have many safety concerns in common, however, in Japan, ongoing studies are only conventional studies, such as post-marketing surveillance studies or all-cases studies, while the U. S. conducts studies to meet each individual requirement need. Ideal post-marketing safety study designs proposed by the task force, seemed beyond sponsors capabilities, particularly with regard to conduct studies with control group, and require involvement of academia external research organizations, or establishment of the national registry system for cancer and other major diseases.<br>Conclusion: In Japan, Risk Management Plan (RMP) will soon be implemented in 2013, and that is expected to secure patientsʼ safety by the scientific pharmacovigilance plan with the international standard. It is an urgent task to discuss what plan is feasible in Japan and how to make the corporation of industry-government-academia a reality. (Jpn J Pharmacoepidemiol 2012; 17 (1): 55-66)

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Details 詳細情報について

  • CRID
    1390001204484085376
  • NII Article ID
    130003297460
  • DOI
    10.3820/jjpe.17.55
  • ISSN
    1882790X
    13420445
  • Text Lang
    ja
  • Data Source
    • JaLC
    • Crossref
    • CiNii Articles
  • Abstract License Flag
    Disallowed

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