NHS European Office

Paediatric Medicines

baby being examined

The 2006 Paediatric Regulation, which came into force on 26 January 2007, aims to meet three main objectives:

  • to ensure high-quality research into the development of medicines for children;
  • to ensure, over time, that the majority of medicines used by children are specifically authorised for such use, with appropriate forms and formulations, thus reducing the level of off-label use;
  • to ensure the availability of high-quality information about medicines used by children.

In 2013, the European Commission published a first report on the Paediatric Regulation and while it revealed some signs of progress, it found that, due to the length of medicinal products' development, it would take at least 10 years to gain a full understanding of the situation. 

The Commission has since published a second report in October 2017, ten years since the Regulation came into force, which concluded that The Paediatric Regulation has had a very positive impact on paediatric drug development and has led to:

  • more medicines for children as well as better and more information for prescribers and patients;
  • better paediatric research and development;
  • more regulatory support for paediatric matters and
  • paediatrics now being an integral part of medicine development. 

More information on the EU and children’s medicines.

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