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.