MIDD in Japan- Implementations, challenges and opportunities.

In Japan, there has been a growing adoption of Model Informed Drug Development (MIDD) approaches as the rationale for optimal dose decision and modeling outputs have supported better characterizing the risk-benefit profile of a drug by accelerating development period and regulatory-approval pathways. Three primary guidelines on pharmacometric analysis tools issued in Japan between 2019 and 2020 function as a shared communication medium between pharmaceutical companies and the regulatory agency in Japan and have contributed to increasing number of MIDD applications embedded into new drug application documents. This review article describes how the Pharmaceuticals and Medical Devices Agency have been promoting the adoption of modeling and simulation and how MIDD applications have been implemented in Japan by introducing multiple case studies. The intent is to share the knowledge and to promote the harmonization of regulations globally for accelerating the appropriate utilization of MIDD tools and implementation of various new technologies. (149 words).