In Europe, children represent more than 20% of the population. However, before the European Paediatric Regulation (EC) N. 1901/2006 entered into force in January 2007, more than 70% of marketed drugs did not include a paediatric authorisation and has not been properly tested and presented for children.
The article “Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?”, developed within TEDDY—European Network of Excellence for Paediatric Research by Maddalena Toma (researcher at Fondazione Benzi) as first author, was published on the journal Frontiers in Medicine – Regulatory Science.
It aims to investigate the effects of the Regulation (EC) N. 1901/2006 with respect to satisfying the paediatric therapeutic needs, by assessing the new Paediatric medicinal products (MP) approved by the European Medicines Agency (EMA) in the period January 2007 to December 2019.
The search for EMA approved paediatric medicines was performed on the TEDDY- European Paediatric Medicines Database – EPMD.
Authors highlight that during the period 2007–2019, 296 MPs (34% of the total MPs) were approved as paediatric medicines by EMA but only 175 were active substances authorised with a new paediatric indication, dosage or formulation. Among them 47 were repurposed according to the well-established use procedure.
Positive results of the Paediatric Regulation approval include an increase of paediatric innovative biological medicinal products, in specific conditions (oncology, rare disease, hepatitis C and HIV infection etc.), and three paediatric Advanced Therapies. Moreover, an increased number of paediatric clinical studies supporting the marketing authorisation was observed.
However, the paediatric versus total medicinal products ratio remained stable compared to the period 1995-2006 and the number of medicines approved for newborns and infants is very low; overall only the 22% (38) of the approved paediatric medicines cover all the age groups.
This work underlines that the reasons for the limited development of paediatric medicines in Europe need to be further discussed and that new measures in support of the Regulation should be implemented.
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