The article “Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a paediatric perspective” has been published in the journal Frontiers in Medicine on March 28, 2024.
This work was born in the context of the collaboration between researchers from Fondazione Gianni Benzi onlus and EPTRI, the European Paediatric Translational Research Infrastructure.
The purpose of this work was to analyse the potential paediatric interest of the methodologies qualified as “new methodologies for drug development” by the European Medicines Agency (EMA). It was found that 70% of the 27 methodologies qualified by the EMA were potentially of interest to paediatric patients, but only six of them reported paediatric data.
The paper emphasizes the importance of implementing innovative methodologies in regulatory-compliant paediatric research activities. Dedicated paediatric research infrastructures, which provide regulatory support and strategic advice during research activities, could be crucial for designing paediatric ad hoc methodologies or extending and validating them for paediatrics.
The article is available for free here.

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