Abstract
Eighty percent of drug administration in children is for unapproved indication and/or with unapproved dosage and administration, namely “off-label use.” In US and EU, in line with the ideas under ICH E11 guideline, developments of drugs for children have been encouraged, bringing about significant changes in environment surrounding pediatric drug products. This document intends to introduce current status of pediatric drug development in Japan and abroad and to introduce examples of efforts, which have been made for the past 15 years to promote pediatric drug development, by the Japan Pharmaceutical Manufacturers Association composed of pharmaceutical industries in collaboration with academia through Health and Labor Sciences Researches.
