Extrapolation of efficacy and safety in paediatric medicine development - Scientific guideline

This document proposes a framework for extrapolation of data from adults to children which could serve as a basis for regulatory decision making in planning and developing paediatric developments, including paediatric investigation plans.

Keywords: Paediatrics, extrapolation, medicine development, biostatistics, modelling and simulation

Current version

Adopted reflection paper on the use of extrapolation in the development of medicines for paediatrics - Revision 1

Adopted Reference Number: EMA/189724/2018 Summary:

This document proposes a framework for extrapolation of data from adults to children which could serve as a basis for regulatory decision making in planning and developing paediatric developments, including paediatric investigation plans.

Document history

Adopted reflection paper on the use of extrapolation in the development of medicines for paediatrics - Revision 1

Adopted Reference Number: EMA/189724/2018 Summary:

This document proposes a framework for extrapolation of data from adults to children which could serve as a basis for regulatory decision making in planning and developing paediatric developments, including paediatric investigation plans.

Overview of comments received on ' Reflection paper on the use of extrapolation in the development of medicines for paediatrics ' (EMA/189724/2018) - Revision 1

Reference Number: EMA/696705/2018

Draft reflection paper on the use of extrapolation in the development of medicines for paediatrics - Revision 1

Draft: consultation closed Consultation dates: 13/10/2017 to 14/01/2018 Reference Number: EMA/199678/2016

Draft reflection paper on extrapolation of efficacy and safety in paediatric medicine development - First version

Draft Reference Number: EMA/199678/2016

Concept paper on extrapolation of efficacy and safety in medicine development

Adopted Reference Number: EMA/129698/2012 Summary:

The concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation.