Children need new medicines

There are not enough studied and safe medicines for children in Europe (approx. 100 million children aged 0 to 17 years in the EU, of whom 1.1 million in Finland). In clinical practice, common pediatric pharmacotherapy relies largely on medicines intended for adult use for which there is no research data on long-term effects or adverse effects on children. Therefore, it is very important that medicines are studied also in child populations in addition to adults to ensure that children and adolescents will have new medicines for the prevention and treatment of various diseases.

This development is supported by new legislation. In 2007, the Paediatric Regulation (EU 1901/2006) came into force. This regulation includes a requirement that the pharmaceutical industry conducts clinical trials with medicinal products also on children if the European Medicines Agency (EMA) judges that the medicine is essential and needed in the treatment of pediatric diseases. Furthermore, the regulation included an obligation for EMA to establish a European network for coordinating other research networks in Europe. This European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) was launched in 2010 and FINPEDMED has been a member of this network ever since.