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Assessment of regulatory efforts to facilitate the approval of off-label drugs

Research Project

Project/Area Number 24590619
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical sociology
Research InstitutionTokai University (2015)
Osaka University (2014)
Kyushu University (2013)
Nagasaki University (2012)

Principal Investigator

SHIMAZAWA Rumiko  東海大学, 医学部, 教授 (00411083)

Co-Investigator(Kenkyū-buntansha) IKEDA Masayuki  香川大学, 医学部, 客員研究員 (10242215)
Project Period (FY) 2012-04-01 – 2016-03-31
Project Status Completed (Fiscal Year 2015)
Budget Amount *help
¥5,200,000 (Direct Cost: ¥4,000,000、Indirect Cost: ¥1,200,000)
Fiscal Year 2015: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2014: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2013: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Fiscal Year 2012: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
Keywordsレギュラトリーサイエンス / 適応外使用 / 公知申請 / コンペンディウム / コンパニオン診断 / CBRN対策
Outline of Final Research Achievements

This study sought to investigate the factors that contribute to the approval of individual applications through an analysis of review reports and to assess the outcome of efforts to facilitate the approval of off-label drugs by the public knowledge approval system that has been used for over a decade in Japan. Prior approval by foreign authorities, although important, did not appear to be essential for approval in Japan. Substantiating safety and effectiveness of agents by means of standard textbooks or guidelines was used consistently to obtain approval for off-label use. In addition, we investigated the relation between evidence and approval relating to companion diagnostics and medical countermeasures against chemical, biological, radiological and nuclear (CBRN) agents in Japan.

Report

(5 results)
  • 2015 Annual Research Report   Final Research Report ( PDF )
  • 2014 Research-status Report
  • 2013 Research-status Report
  • 2012 Research-status Report
  • Research Products

    (14 results)

All 2016 2015 2014 2013 2012

All Journal Article (13 results) (of which Peer Reviewed: 13 results,  Open Access: 2 results,  Acknowledgement Compliant: 6 results) Presentation (1 results) (of which Invited: 1 results)

  • [Journal Article] Drug-diagnostic co-development: challenges and issues2016

    • Author(s)
      Shimazawa R, Ikeda M
    • Journal Title

      Expert Review of Molecular Diagnostics

      Volume: 16 Issue: 2 Pages: 187-204

    • DOI

      10.1586/14737159.2016.1132163

    • Related Report
      2015 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety2016

    • Author(s)
      Shimazawa R, Ikeda M
    • Journal Title

      Personalized Medicine

      Volume: 13 Issue: 2 Pages: 155-67

    • DOI

      10.2217/pme.15.51

    • Related Report
      2015 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Development of drug-approval regulations to medical countermeasures against chemical, biological, radiological, or nuclear agents in Japan2015

    • Author(s)
      Shimazawa R, Ikeda M
    • Journal Title

      Health Security

      Volume: 未定 Issue: 2 Pages: 130-138

    • DOI

      10.1089/hs.2014.0068

    • Related Report
      2015 Annual Research Report
    • Peer Reviewed / Open Access / Acknowledgement Compliant
  • [Journal Article] International differences in companion diagnostic approvals: How are we able to manage the differences?2015

    • Author(s)
      Shimazawa R, Ikeda M.
    • Journal Title

      Expert Review of Molecular Diagnostics

      Volume: 15 Issue: 2 Pages: 157-159

    • DOI

      10.1586/14737159.2015.969243

    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Open Access / Acknowledgement Compliant
  • [Journal Article] Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan.2014

    • Author(s)
      Shimazawa R., Ikeda M.
    • Journal Title

      Journal of Clinical Pharmacy and Therapeutics

      Volume: 39 Issue: 2 Pages: 210-214

    • DOI

      10.1111/jcpt.12129

    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Guidance for peptide vaccines for the treatment of cancer.2014

    • Author(s)
      Yamaguchi Y, Yamaue H, Okusaka T, Okuno K, Suzuki H, Fujioka T, Otsu A, Ohashi Y, Shimazawa R, Nishio K, Furuse J, Minami H, Tsunoda T, Hayashi Y, Nakamura Y
    • Journal Title

      Cancer Science

      Volume: 105 Issue: 7 Pages: 924-931

    • DOI

      10.1111/cas.12443

    • NAID

      120006986476

    • Related Report
      2014 Research-status Report
    • Peer Reviewed
  • [Journal Article] Conflicts of interest in psychiatry: strategies to cultivate literacy in daily practice2014

    • Author(s)
      Shimazawa R, Ikeda M.
    • Journal Title

      Psychiatry and Clinical Neurosciences

      Volume: 68 Issue: 7 Pages: 489-497

    • DOI

      10.1111/pcn.12201

    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom, and Japan.2013

    • Author(s)
      Shimazawa R., Ikeda M.
    • Journal Title

      Journal of Clinical Pharmacy and Therapeutics

      Volume: 38 Issue: 6 Pages: 468-475

    • DOI

      10.1111/jcpt.12089

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] Are there any differences in the regulations of personalised medicine among the US, EU, and Japan?2013

    • Author(s)
      Shimazawa R., Ikeda M.
    • Journal Title

      British Journal of Clinical Pharmacology

      Volume: 75 Issue: 5 Pages: 1365-1367

    • DOI

      10.1111/j.1365-2125.2012.04462.x

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] Safety information in drug labeling: a comparison of the USA, the UK, and Japan2013

    • Author(s)
      Rumiko Shimazawa and Masayuki Ikeda
    • Journal Title

      Pharmacoepidemiology and Drug Safety

      Volume: 22 Issue: 3 Pages: 306-318

    • DOI

      10.1002/pds.3408

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] Japanese regulatory system for approval of off-label drug use: Evaluation of safety and effectiveness in literature-based applications2012

    • Author(s)
      Shimazawa R, Ikeda M
    • Journal Title

      Clin Ther

      Volume: 34 Issue: 10 Pages: 2104-16

    • DOI

      10.1016/j.clinthera.2012.09.004

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] The vaccine gap between Japan and the UK2012

    • Author(s)
      Shimazawa R., Ikeda M.
    • Journal Title

      Health Policy

      Volume: 107 Issue: 2-3 Pages: 312-317

    • DOI

      10.1016/j.healthpol.2012.05.012

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] Delays in psychiatric drug development in Japan2012

    • Author(s)
      Shimazawa R., Kusumi I., Ikeda M.
    • Journal Title

      Journal of Clinical Pharmacy and Therapeutics

      Volume: 37 Issue: 3 Pages: 348-351

    • DOI

      10.1111/j.1365-2710.2011.01311.x

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Presentation] 新薬承認審査での品質分野2013

    • Author(s)
      嶋澤るみ子
    • Organizer
      日本PDA製薬学会第20回年会
    • Place of Presentation
      タワーホール船堀(東京)
    • Related Report
      2013 Research-status Report
    • Invited

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Published: 2013-05-31   Modified: 2019-07-29  

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