Academic Clinical Trials and Drug Regulations in Japan: Impacts of Introducing the Investigational New Drug System

Hisashi Urushihara, Koji Kawakami

研究成果: Review article査読

抄録

In Japan, academic clinical trials do not generally need to be conducted under good clinical practice and cannot therefore be used for regulatory submission for marketing authorization of new medical products. We reviewed 2 differential regulatory systems governing clinical trials in Japan and the development histories of 2 case products whose clinical trials at the early development stage were conducted by academic researchers and transferred to the private sector for further development toward commercialization in Japan. We further estimated that the introduction of the investigational new drug system may have accelerated the development of tocilizumab, an antibody drug for rheumatoid arthritis, at best by 2 years by utilizing the results of early exploratory clinical trials conducted by academic investigators. Similarly, an enlarged indication for JACE®, a cultured epithelium autograft for severe burns, would have been expected at launch by utilizing the results of academic trials investigating various indications. These possible impacts and estimations would warrant introducing the investigational new drug system into Japan drug regulatory system.

本文言語English
ページ(範囲)463-472
ページ数10
ジャーナルTherapeutic Innovation and Regulatory Science
48
4
DOI
出版ステータスPublished - 2014 7
外部発表はい

ASJC Scopus subject areas

  • 薬理学、毒性学および薬学(その他)
  • 公衆衛生学、環境および労働衛生
  • 薬理学(医学)

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