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

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Document details

Download document Concept paper on the revision of the guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population
Reference number EMA/CHMP/448599/2016
Status draft: consultation open
First published 2017-05-04
Last updated 2017-05-04
Consultation start date 2017-05-04
Consultation end date 2017-07-31
Email address for submissions pkwp@ema.europa.eu

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.