2018 Volume 8 Issue 3 Pages 179-183
The Clinical Trials Act in Japan has been enforced in April 2018. Since clinical research plan would be confirmed objectively by certified review board, atmosphere to conduct high quality clinical research would be cultivated, which will result in activation of clinical studies finally. Therefore, pharmaceutical industries expect the Act quite positively based on the following perspectives. i) The Act will induce to improve quality of clinical research, which must be a trigger to activate whole of clinical studies. ii) Result of specified clinical research would be utilize for regulatory submission data package. iii) The Clinical Trials Act and new regulations such as conditional early approval system would synergistically accelerate to make answer for a research question. iv) Both value and innovation of new medicine would be evaluated by proper clinical research. To activate whole clinical studies and to maximize objective of the Act, effective collaboration between clinical site and company should be established under sharing of role and responsibility.
