Module232025

12/05/2025

Paediatric Requirements in Drug Development – When are the Paediatric Study Plans Required?

Lead “Adult” Product Development

USA (iPSP) End Phase 2 60 days EOP2 Meeting

EU (PIP) Availability of PK Data in Adults End Phase 1

Global Optimization

Exploratory Target to Hit

Hit to Lead Optimization

First Human Dose

Phase III

Submit

Global Launch

Phase IA

Phase IB / II

Paediatric Study Plan

Paediatric Plan Development

PPSR -> Written Request

Paediatric Investigational Plan (PIP)

Paediatric Plan Discussion

Applicants are welcome to submit their PIP

Formulation & Toxicology Work

applications during or even before initial PK studies in adults

Paediatric Study Initiation

The Organisation for Professionals in Regulatory Affairs

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Sponsor Requirements: iPSP and PIP

iPSP/PIP must include an outline of the paediatric study or studies that the sponsor plans to conduct including (as able) study objectives and design, age groups, sample size, relevant endpoints, statistical approach, and timelines for protocol submission Sec 505B of the FD&C Act and EU Paediatric Regulation requires sponsors to have an agreed initial Pediatric Study Plan(iPSP) to submission of original NDA/BLA and an agreed PIP prior to submission of MAA

FDA and EMA encourages early communication between developers and regulators

Statute provides for early meeting with FDA and EMA to discuss development of iPSP and PIP respectively

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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