Document details


Download document Draft guideline on pharmaceutical development of medicines for paediatric use
Reference number EMA/CHMP/QWP/805880/2012 Rev. 1
Status draft: consultation open
First published 04/01/2013
Last updated 04/01/2013
Consultation start date 04/01/2013
Consultation end date 31/03/2013
Email address for submissions




This guideline is intended to provide additional guidance for the pharmaceutical development of medicinal products for children from birth to less than 18 years of age. This guideline should be read in conjunction with all other relevant EU legislative and guiding documents (see section 3). 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.


Posted on the EMA website on 4 January 2013