Developing better medicines for children

Children and teenagers have previously been somewhat overlooked by the pharmaceutical industry in the development of new medicines.

Use of medicines in children is mostly based on empirical data obtained from adults, without dedicated studies in children, or the research information might be from another party than the original developer of the medicine. Children are also treated with dosage forms that are not designed for children.

In 2007, the European Commission issued a regulation on medicinal products for paediatric use. Its main purpose is to increase the availability of medicines that have been developed for and found suitable for children. The regulation lays down that all new medicines intended to be marketed in the EU must have a paediatric investigation plan for developing the medicine for children, unless there is a valid reason not to have one. The paediatric investigation plan needs to be approved by the European Medicines Agency.

The purpose of the regulation is

• to promote the development of new medicines and suitable (child-friendly) dosage forms for treatment of children
• to ensure that medicines intended for children are based on high-quality research and undergo a regulatory authorisation
• to avoid unnecessary or excessive clinical experiments on children
• to increase and improve the available information on the effects of medicines on children.