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The ICH E11A Guideline reaches Step 4 of the ICH Process (Catapult’s regulatory round-up – August 2024)

The E11A Guideline provides recommendations and promotes international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines. It provides a framework for using extrapolation to support paediatric drug development.

The framework describes the process for understanding the existing information available, the gaps in information needed to inform development, and ways to generate additional information when required and recommends approaches to assessing factors that influence the determination of similarity of disease, drug pharmacology, and response to treatment between a reference and paediatric target population. In addition, it discusses how the characteristics of the disease, drug pharmacology and response to treatment may influence this determination.

This guideline has now reached step 4, adoption stage of the ICH process.

Published on the 30th of August 2024 in Catapult’s regulatory round-up for August 2024.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). The ICH E11A Guideline reaches Step 4 of the ICH Process (Catapult’s regulatory round-up – August 2024). ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/12mjy


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