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

Hisashi Urushihara, Koji Kawakami

Research output: Contribution to journalReview article

Abstract

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.

Original languageEnglish
Pages (from-to)463-472
Number of pages10
JournalTherapeutic Innovation and Regulatory Science
Volume48
Issue number4
DOIs
Publication statusPublished - 2014 Jul
Externally publishedYes

Keywords

  • academic researchers
  • clinical trial directive
  • clinical trials
  • drug legislation
  • economic impact analysis
  • investigational new drug

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)

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