Module232025

12/05/2025

PMDA Pediatric Drugs Working Group

• An across office project team in the PMDA, since November 2011

External communications (stakeholders like academics and patients)

International collaborations (Paediatric Cluster)

Members from Offices of New Drugs, Safety, Regulatory Science, etc.

Analyses (analyse and identify paediatric issues raised in past reviews and consultations)

Internal Communications (review teams)

The Organisation for Professionals in Regulatory Affairs

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• Since 1 July, 2024; Consultation Center of Pediatric and Orphan Drugs Development (CCPODD) • Q & A for “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults” • Consultation should occur: • When planning to conduct a paediatric clinical trial and has already conducted scientific consultation for adult indication with the PMDA, AND • Before filing an application for approval in adults • To confirm the paediatric development plan, which leads to an additional premium on the NHI Drug price list Consultation on Confirmation of Paediatric Drug Development Program

The Organisation for Professionals in Regulatory Affairs

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