ICH guideline E11A on pediatric extrapolation - Scientific guideline

This guideline provides recommendations for harmonised approaches for paediatric extrapolation to support the development and authorisation of paediatric medicines. It provides a framework for using extrapolation as a tool to support paediatric drug development that encompasses an iterative process for understanding the existing information available, the gaps in information needed to inform development and ways to generate additional information when needed.

Please note that a case example has been generated to help contextualise the main document and further inform the public consultation process.

Keywords: Paediatric medicinal product development, children, adolescents, extrapolation, pharmacokinetic, modelling and simulation, statistics

Current effective version

Draft ICH guideline E11A on pediatric extrapolation Step 2b

Consultation dates: 06/04/2022 to 06/08/2022Draft: consultation closedReference Number: EMA/CHMP/ICH/205218/2022Summary:

This guideline provides recommendations for harmonised approaches for paediatric extrapolation to support the development and authorisation of paediatric medicines. It provides a framework for using extrapolation as a tool to support paediatric drug development that encompasses an iterative process for understanding the existing information available, the gaps in information needed to inform development and ways to generate additional information when needed.

Comments should be provided using this template. The completed comments form should be sent to [e-mail].

Overview of comments received on ICH guideline E11A on pediatric extrapolation Step 2bEMA/CHMP/ICH/205218/2022

Reference Number: EMA/CHMP/ICH/205218/2022 Corr.