EMA: Draft guideline on pharmaceutical development of medicines for paediatric use

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.