Implementation of Japan’s First Clinical Research Regulatory Law: Background, Overview, and Challenges
- 27 Downloads
In April 2018, Japan’s first law regulating clinical research went into effect. The law aimed to strengthen regulations on research integrity and conflicts of interest, which had been limited under existing administrative guidelines; the law also provided stipulations for legal penalties. The scope of the new regulations, however, is limited entirely to studies that evaluate unapproved drugs or the off-label use of approved drugs, and those that receive funding from companies. On the other hand, the law’s application brings numerous complications, including the establishment of new review committees, troublesome procedures for transitioning studies that are currently underway, and ambiguities about the scope of what constitutes best efforts. Thus, the change has led to substantial strain and confusion in the field. This paper offers an overview of the law and its background, and discusses its future prospects from the practical standpoint of managing ethics committees and providing research ethics support in the field.
KeywordsResearch regulation Law Ethics committee Japan
AkA: conceptualization, writing—original draft, writing—review and editing. EN: conceptualization, formal analysis, writing—review & editing. ArA: conceptualization, formal analysis, writing—review and editing
Funding was provided by Pfizer Health Research Foundation.
Compliance with Ethical Standards
Conflict of interest
Akira Akabayashi is President of the Japan Association for Bioethics; this paper reflects the author’s personal academic analyses and opinions and does not represent JAB’s official position. Both Akira Akabayashi and Eisuke Nakazawa get a grant from Medical Technology Practical Application and a General Promotion Support Grant from the Japan Agency for Medical Research and Development (AMED), however, no money is used from the grant for this study.
- Clinical Trials Act. (2017). https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000213334.pdf.