By setting mandatory requirements, paediatric regulations implemented in the EU and the US have allowed the development of – and improved access to – high-quality drugs for the paediatric population. It is acknowledged that paediatric development remains a challenge in many circumstances and, ten years after the implementation of the EU Paediatric Regulation, associated requirements are still seen as constraints by industry. Early planning and interactions with regulators on paediatric development have been proven to facilitate, to a certain extent, agreement on a plan and its integration into a global development plan. This article addresses some of the challenges faced by sponsors to integrate the paediatric population in the overall drug development plan, which often aims at being “global”, ie, global from a population point of view (including both adults and children) and also from a geographical perspective (eg, the EU and the US).
Keywords
Paediatric population; Paediatric Regulation; Paediatric investigation plan (PIP); Paediatric study plan (PSP); Best Pharmaceuticals for Children Act; Paediatric Research Equity Act; Global drug development; Extrapolation; Modelling; Simulation.
Published on: July, 2017
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