Article from TOPRA, Regulatory Rapporteur – Vol 11, No 3, March 2014
Since the entry into force of the Paediatric Regulation in 2007, a number of concerns have been raised by both industry and regulators on the practicalities of paediatric investigation plans (PIPs) for the development of medicines in children. From experiences thus far, it is clear that some of the procedural requirements and challenges for PIP assessments and opinions still need to be addressed. While some new initiatives are now in place, other aspects are still found wanting. This article examines the issues surrounding early PIP submissions, and the thorny question of when a candidate drug for an adult indication does, or does not, have any potential use in a paediatric condition. The current efforts to simplify and harmonise opinions among the various relevant EMA committees are also discussed.
Author: Dirk Mentzer, Chair, Paediatric Committee (PDCO), and Head of Pharmacovigilance Unit, Paul-Ehrlich-Institut (PEI), Frankfurt, Germany.
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