In April 2022, the European Medicines Agency adopted the ICH guideline E11A on pediatric extrapolation. This guideline provides recommendations for harmonised approaches for paediatric extrapolation to support the development and authorisation of paediatric medicines. Harmonisation of the approaches to paediatric extrapolation should reduce the likelihood of substantial differences between regions as well as the exposure of paediatric populations to unnecessary clinical trials and facilitate more timely access to paediatric medicines globally.

It aims to provide 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.

Read the guidelines here!