Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?

Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?

Objectives: In this paper, we investigated the effects of the European Paediatric Regulation (EC) N° 1901/2006 with respect to satisfying the paediatric therapeutic needs, assessed in terms of the increased number of paediatric medicinal products, new therapeutic indications in specific high-need co...

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Bibliographic Details
Main Authors: Maddalena Toma, Mariagrazia Felisi, Donato Bonifazi, Fedele Bonifazi, Viviana Giannuzzi, Giorgio Reggiardo, Saskia de Wildt, Adriana Ceci, TEDDY European Network of Excellence for Paediatric Research
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-02-01
Series:Frontiers in Medicine
Subjects:
EU paediatric regulation
paediatric medicines
paediatric age
therapeutic areas
paediatric clinical studies
paediatric repurposing
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2021.593281/full

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https://www.frontiersin.org/articles/10.3389/fmed.2021.593281/full

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