Mitigate Japan's Drug Loss With Model‐Informed Drug Development

'Drug loss' in Japan refers to drugs that have been approved and marketed overseas but haven't been developed, submitted, or approved in Japan. A comprehensive Model-Informed Drug Development (MIDD) strategy, enhanced with artificial intelligence/machine learning, can minimize drug loss. Continued pharmaceutical industry and regulatory commitment and collaboration in applying MIDD will facilitate Japanese patients' access to essential medicines and solidify Japan's role in global pharmaceutical advancement.