How the clinical research act will change clinical research in Japan

The Clinical Research Act went into force on April 1, 2018, marking a major shift in clinical research in Japan. Moving forward, review of research plans by a Certified Review Board authorized by the Minister of Health, Labour and Welfare will be necessary when conducting clinical research using pharmaceuticals or medical devices which are off-label or have not been approved, or when conducting clinical research supported by company funding. Moreover, even currently ongoing research will need to be reviewed by a Certified Review Board during the transition period. The main feature of the Clinical Research Act is that only one review by a Certified Review Board will be needed for multicenter studies. That is, ethics review by each participating institution is no longer necessary. While criteria that must be adhered to under the new Act are substantially the same as the rules that have been in place for dinical trials, there are also notable differences, including reporting of adverse events, compensation for health injury, conflict of interest management, and registration in a new clinical trial registry database.