Paediatric medicines in the EU, the UK and the U.S.: regulatory framework in a nutshell

In a recently published Practice Note commissioned by LexisPSL, our life sciences experts look at the EU and the UK regulations in paediatric medicines, interspersed with insights from a US perspective. This Practice Note thoroughly analyses the legislative framework in both the EU and UK and provides an overview of the key obligations and incentives for pharmaceutical companies that were introduced to increase the number of paediatric studies and approved paediatric drugs. As a new proposal for the EU Paediatric Regulation is expected, the authors also undertake a critical review of the efficacy of the current European framework.