Pharmaceutical development of medicines for paediatric use - Scientific guideline

This document provides guidance on the pharmaceutical development of medicinal products for children between birth and 18 years of age.

Keywords: Pharmaceutical development, quality, child, paediatric formulation, paediatric investigation plan (PIP)

Current effective version

Guideline on pharmaceutical development of medicines for paediatric use

Adopted Reference Number: EMA/CHMP/QWP/805880/2012 Rev. 2 Summary:

The “Paediatric Regulation” aims to facilitate the development and accessibility of age-appropriate paediatric medicines. This aim should be achieved without subjecting children to unnecessary clinical trials and without delaying the authorisation of medicinal products for other age groups.

Document history - Revision 2

Guideline on pharmaceutical development of medicines for paediatric use

Adopted Reference Number: EMA/CHMP/QWP/805880/2012 Rev. 2 Summary:

The “Paediatric Regulation” aims to facilitate the development and accessibility of age-appropriate paediatric medicines. This aim should be achieved without subjecting children to unnecessary clinical trials and without delaying the authorisation of medicinal products for other age groups.

Document history - Revision 1

Overview of comments on 'guideline on pharmaceutical development of medicines for paediatric use' received during the second public consultation

Reference Number: EMA/805826/2012

Draft guideline on pharmaceutical development of medicines for paediatric use

Draft: consultation closed Consultation dates: 04/01/2013 to 31/03/2013 Reference Number: EMA/CHMP/QWP/805880/2012 Rev. 1 Summary:

This guideline is intended to provide additional guidance on the pharmaceutical development of medicinal products for children from birth to less than 18 years of age. It should be read in conjunction with all other relevant European Union legislative and guiding documents. The guideline takes due account of the scientific and technical progress in the manufacture and control of paediatric medicines at the date of coming into operation.

Document history - First version

Overview of comments received on 'guideline on pharmaceutical development of medicines for paediatric use' (EMA/CHMP/QWP/180157/2011)

Reference Number: EMA/805826/2012

Draft guideline on pharmaceutical development of medicines for paediatric use

Draft: consultation closed Consultation dates: 01/05/2011 to 31/12/2011 Reference Number: EMA/CHMP/QWP/180157/2011 Summary:

In January 2007 Regulation EC No 1901/2006 (the “Paediatric Regulation”) entered into force. As a result of this Regulation, the number of paediatric formulations that the pharmaceutical industry will have to develop to support their clinical trials will increase.

Concept paper on the development of a quality guideline on pharmaceutical development of medicines for paediatric use

Reference Number: EMEA/138931/2008