Effects of the Paediatric Regulation funding on the development of off-patent medicines in children.

ABSTRACT:

Introduction

In paediatrics, medicines repurposing is a particularly advantageous approach, offering a route to address unmet medical needs and turn off-label use into evidence-based treatments for paediatric populations. This study analysed the effects of funds provided under the Seventh Framework Programme for Research (FP7-FRP), issued by the European Commission from 2007 to 2013 according to the European Paediatric Regulation, in terms of new paediatric marketing authorisations (MAs) including paediatric Use Marketing Authorisations (PUMAs). Additionally, we investigated which funded projects included repurposing initiatives.

Methods

Data was collected on paediatric Investigation Plans (PIPs), new MAs, and MAs variations from the EMA website, national medicine registers,

SUBMITTER: Ruggieri L 

PROVIDER: S-EPMC11823639 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature