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Planning paediatric development when key evidence is still emerging
On February 12, 2026, EMA published a review of its stepwise Paediatric Investigation Plan pilot. Between 2023 and 2025, the pilot received 27 eligibility requests and eight stepwise PIPs were adopted, mainly in rare diseases and oncology.
The approach addresses exceptional programmes where crucial information is not yet available to define a full PIP. It allows a partial plan to be developed further through agreed steps as evidence becomes available. It does not remove the need for a complete development plan.
For ITCC-P4, this illustrates the importance of asking what evidence is needed at each decision point. Depending on the programme, a review of molecular information or targeted preclinical evaluation may help resolve specific uncertainties about a medicine’s paediatric potential.