More than 5 years of European Paediatric Regulation: statistics and industrial experience.

The aim of the European paediatric legislation is to ensure high quality paediatric clinical research, and subsequently increase availability of authorised medicines that are appropriate for children and produce better information on medicines. One of the main pillars of the regulation is the paediatric investigation plan (PIP), a new key document in the general drug development process. PIP submission and approval are now mandatory to ensure registration of a new drug in the EU. A short summary of the achievements from the introduction of the regulation in 2007 is given. In addition, PIP case studies are presented to illustrate the challenges associated when working within the framework of the new process.