[S27] For the promotion of the pediatric drug development

Fri. Mar 29, 2024 3:30 PM - 5:30 PM [Room 502] Conference Center 502 (5F)

Organizer: Mayumi Shikano (Tokyo Univ. Sci.)

In general, developing drugs for children is sluggish in all countries due to its small market size and difficulty of conducting pediatric studies. To address this issue, formulation of pediatric study plans by development companies of adult drugs is legally required in the US and Europe. Various measures to promote pediatric drug development have been taken in Japan as well. However, in spite of these efforts, the delay or lack of pediatric drug development has become a major social concern.
In the symposium, Shikano will discuss the reason for the sluggish of pediatric drug development in Japan based on the questionnaire surveys on pharmaceutical industries and medical institutes. Hayashi will report the history and the latest information on policies to promote pediatric drug development in the US and Europe including their operational issues.
Following these presentations, Nakamura will introduce efforts of Japan Pediatric Society and related academic bodies, which are expected to make a significant contribution to the promotion of pediatric clinical trials. Finally, Bun will present the latest government of Japan's efforts toward the promotion of pediatric drug development, including drug pricing incentive. The symposium will consequently indicate the future direction of Japanese academia and the regulation to make further efforts to promote pediatric drug development.