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

作者：Urushihara Hisashi; Kawakami Koji^*

来源：Therapeutic Innovation & Regulatory Science, 2014, 48(4): 463-472.

DOI：10.1177/2168479014522044

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

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 (R), 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.

• 出版日期2014-7