Five years after the European Commission introduced new regulations to improve the standing of treatments specifically for use in children, one in five new medicines licensed in Europe has a paediatric indication.
The EC’s Paediatric Regulation was put in place in 2008 to increase the number of medicines specifically developed for children.
It has since underpinned the authorisation of 31 medicines for children, from a total of 152 new products approved, but long development cycles mean it will take at least five more years for legislation’s full impact to be seen.
The EC’s commission for health and consumer policy Tonio Borg said: “Children are not small adults. They require tailored medical treatments.
“I am pleased to see that in five years, progress has been made on research and the safety of children’s medicines, and I hope that this marks the beginning of a much needed paradigm shift.”
He added that the pharmaceutical industry had “responded positively” to the EC’s call for better and safer research, more medicines for children on the EU market and more information for parents and health professionals.
“I am very satisfied about this positive shift and will do my utmost to keep it going,” he said.
The EC also highlighted the role of its Paediatric Investigation Plans (PIPs), which aim to ensure tests for the potential of new products to treat children become an integral part of the overall product development.
By 2012 the European Medicines Agency (EMA) had agreed 600 PIPs, and it expects “many more of them will be completed in the next five years”.
To address the lack of adequate information on the use of medicines in children, the Paediatric Regulation requires that companies submit their data on safety of efficacy of products authorised for use by children, to the competent authorities.
Since 2008 more than 18,000 studies on roughly 2,200 medicinal products have been submitted to the competent authorities.
But while the report showed considerable improvements for the development of medicines for children, the EC said it would continue to monitor the implementation of the Paediatric Regulation.