EMA – Publication of the Rev. 12 of the Procedural advice on paediatric applications – Guidance for applicants
The EMA recently updated its “Procedural advice on paediatric applications” document. This guidance document provides comprehensive guidance on the procedures for submitting and managing paediatric applications to ensure the safety and efficacy of medicinal products for children. It outlines the requirements for submitting paediatric investigation plans (PIPs), modifications, waivers, and compliance checks, emphasizing the importance of early and continuous dialogue between applicants and the EMA.
This document should be consulted together with the IRIS guide for applicants.
More information and guidance on Paediatric medicines on the EMA Website.
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vroby (19 mai 2025). EMA – Publication of the Rev. 12 of the Procedural advice on paediatric applications – Guidance for applicants. ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/13y69





