Drug Evaluation Committee Survey on the Actual Status of Model-Informed Drug Development through Investigations on Approved Products in Japan
Data Science Expert Committee
October 2023
Task Force 4 of the Drug Evaluation Committee's Data Science Subcommittee in FY2022 will conduct a survey on the actual state of Model-Informed Drug Development (MIDD) mainly for items approved between January 2020 and March 2022, based on the approval information [review reports and summaries of application materials] disclosed by the PMDA. The survey was conducted from various perspectives, such as development phase, drug characteristics, and disease areas, based on the approval information [review reports and summary of application materials] disclosed by PMDA. We hope that this survey will be helpful not only in understanding the actual situation, but also in understanding and disseminating the related notifications (ICH M15, etc.) in the future.
Japan Pharmaceutical Manufacturers Association
Drug Evaluation Committee Data Science Subcommittee
Task Force 4 in FY2022 / Continuing Task Force 4 in FY2023