Module232025

12/05/2025

March 2025

• PMDA will implement the following approach during clinical trial consultations for adult drugs: • When the drug under development is expected to be used in children for the diseases and conditions targeted in adult drug development, PMDA will actively verify the status of pediatric drug development both domestically and internationally. This aims to encourage the initiation of pediatric drug development in Japan without lagging behind other countries. • If requested by the applicant, PMDA will confirm the pediatric drug development plan based on Planning of Pediatric Drug Development Programs during Development of Drugs for Adults • Consultation on clinical trials, Phase II onwards, requires briefing books to include pediatric development plan details from Japan and overseas.

The Organisation for Professionals in Regulatory Affairs

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• PSB/PED Notification No. 0112-3, in force from 1 April 2024 1. Development of pediatric drugs Development of pediatric drugs subject to this notification refers to the development which meet any one or more of the following (1) to (3) based on medical needs. (1) Development to include children in the indications of a drug whose indication is differentiated between adults and children (2) Development to determine appropriate dosage and administration for children (3) Development of pediatric dosage forms different from those for adults Planning of the Paediatric Drug Development Program during Development of Drugs for Adults (1)

The Organisation for Professionals in Regulatory Affairs

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