International harmonisation (clinical trial environment)



  • Clinical trial environment in Japan is improving owing to various efforts to increase efficiency in clinical trials. However, more improvement is required in the area of cost optimization and in increasing the number of subjects per study site.
  • Japan should further enhance the efficiency of drug development by taking advantage of the new guidelines on multi-regional clinical trials (ICH E17, GENERAL PRINCIPLES FOR PLANNING AND DESIGN OFMULTI-REGIONAL CLINICAL TRIALS) that was published in June 2018.