EU Paediatric Regulation (EU 1901/2006)

At the beginning of 2007, the Pediatric Regulation (EU 1901/2006) came into force force in all Member States of the European Union. It aims to improve the health of children in Europe by increasing the development, research and acceptance of medicines needed by children, and by increasing the availability of information related to medicines for children.

The regulation has enabled new suitable, researched and safe medicines to be made available to children. The regulation obliges the pharmaceutical industry to investigate all new adult medicines, including in children and adolescents, if they are deemed necessary and necessary by the EU medicines authorities. A drug designed for adults will not receive a marketing authorization in the EU unless it has also been studied in the paediatric population in accordance with the regulation. Medical authorities can only grant a waiver for this if the disease in question does not occur in children, the use of the medicine would not be safe, or the medicine is judged to be ineffective or useless. In addition, the regulation obliges that the results of studies already carried out, and which will be carried out in the future, must be submitted to the medicines authorities to avoid unnecessary and overlapping studies, and to make use of existing research data.

The development of medicinal products for children is very challenging, as a medicinal product suitable for children should not contain harmful auxiliary or additives, should be in a pharmaceutical form suitable for children (e.g. minitablet, solution, lollipop, straw), should be easily but accurately dispensed and, in addition, should have a sufficiently good taste. The paediatric studies required by the regulation can be used to determine not only the effect properties of the drug, but also these significant practical aspects.