Writing applications for Paediatric Investigation Plans and waivers

Abstract

Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized products under certain circumstances. In principle, the application needs to be submitted early in the development (before completing basic Phase I studies in adults), which may require an innovative and creative approach to the drafting of the necessary documents. The aim of this article is to provide a guide on already existing and available help and advice, to provide further suggestions and comment, and to illustrate common mistakes; the reader should then be able to increase the chances of a more rapid procedure with a higher probability of a positive outcome of the procedure.