Role of pharmacokinetics in the development of medicinal products in the paediatric population - Scientific guideline

This document provides advice on the use of pharmacokinetic studies in paediatric drug development and on methodological issues concerning pharmacokinetic studies in paediatric patients.

Keywords: Children, extrapolation, dose finding, maturation, age, adolescents, newborns, infants, toddlers, pharmacokinetics​​​​​​

Current effective version

Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population

Adopted Reference Number: EMEA/CHMP/EWP/147013/2004 Legal effective date: 01/01/2007

Document history - Revision 1

Concept paper on the revision of the guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population

Draft: consultation closed Consultation dates: 04/05/2017 to 31/07/2017 Reference Number: EMA/CHMP/448599/2016 Summary:

The guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population was adopted by the European Medicines Agency (EMA) Committee for Human Medicinal Products (CHMP) in 2006 with the aim of aiding paediatric drug development. The Paediatric Regulation came into force in the EU in 2007. Since then the EMA Paediatric Committee (PDCO) has approved a large number of Paediatric Investigational Plans (PIPs) and an increasing number of applications for paediatric indications have been submitted to EMA and the national regulatory agencies. A revision to the guideline is therefore proposed to reflect the experience gained over the last decade and developments in science.

Document history - First version (current)

Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population

Adopted Reference Number: EMEA/CHMP/EWP/147013/2004 Legal effective date: 01/01/2007

Overview of comments received on the draft guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population

Reference Number: EMEA/CHMP/EWP/246228/2006