Medicines for children

The absence of suitable authorised medicinal products to treat conditions in children is an issue that has been of concern for some time. Pharmaceutical companies have been reluctant to invest in developing specific treatments or adapting existing medicines to meet the needs of the paediatric population. The studies in children can often be difficult, long and expensive, the market is smaller and therefore of lower commercial interest. In addition, developing a suitable formulation which can provide an accurate dose, for example an oral solution, may be technically difficult and expensive on an industrial scale. This often leaves no alternative to the prescriber than to use 'off-label' and unauthorised products, without evidence-based information to guide prescribers and no information about the risk-benefit assessment.

Hence, the paediatric regulation was developed in order to improve the health of children in the European Union.

The regulation increases the development of medicines for use in children whilst ensuring that these medicines are subject to high quality research and are authorised appropriately for children. At the same time the information available is now improving and made more accessible. A number of new regulatory provisions are now in place which at the end of the day minimise the amount of unnecessary clinical trials in children without delaying the authorisation of medicines in the adult population.

For more information please visit EMA website