ABSTRACT
The Paediatric Regulation highlights in its preamble the problems resulting from the absence of suitably adapted medicinal products and specifically mentions the nonavailability of suitable formulations and routes of administration, as well as the use of magistral or officinal formulations of potentially poor quality. The Paediatric Regulation’s call for adapted formulations implies that products intended for use in children must have an acceptable safety profile also in terms of excipients. The Paediatric Regulation aims at better medicines, including more suitable formulations, for children in Europe. European and worldwide initiatives have been taken during the last years, also related to formulations. The importance of early submission of the pediatric investigation plan is valid also for formulation aspects. The final agreed age groups for which the product is intended will inevitably affect the decision on whether the formulation strategy is optimal, and early agreement on the lower age cut-off will be important for rational formulation development.
