The Paediatric Regulation in the European Union sets up a framework governing mandatory requirements and incentives for industry in the development of new medicinal products as well as a series of accompanying measures to facilitate approaches to gain access and improve the exchange of relevant information on medicinal products in paediatric use. This chapter first presents an overview of the evolvement of the regulatory framework in the European Union and the requirements that have to be met by industry. It describes the role of the European Medicines Agency (EMA) and the main points to consider in discussing Paediatric Investigation Plans (PIP). The second part focuses on the specific implications of this regulatory framework on the development of drug formulations for paediatric populations. Essential elements to ensure suitably adapted formulations are reviewed, focusing on dosing appropriateness, acceptability and safety for all relevant age groups.