Paediatric medicinal products

In recent years, the situation regarding medicines for children has become a focus of discussion, and this discussion is moving in a direction that offers potential for solutions. For a long time, one of the main criticisms was that too few medicines developed specially for children or safe, high-quality medicines adapted to their needs were available. The general lack of reliable data specific to the age groups involved was a further point of criticism. For want of alternatives, medicines are often used in the paediatric setting that have been neither investigated nor authorised for this purpose. At the same time, there has been great reticence about research involving children, who are seen as particularly vulnerable individuals.

Progress in medicines for children

Nowadays, efforts are being made worldwide to bring more child-appropriate medicines onto the market and obtain authorisation for them. In 2007, regulations under EU law entered into force in Europe with the aim of improving the range of medicines available for paediatric use. Since the revised Therapeutic Products Act came into force in 2019, the pharmaceutical industry in Switzerland has also been required to submit a pediatric investigation plan to Swissmedic when applying for marketing authorization for a new drug. Children and adolescents must also be taken into account when developing new drugs. The pediatric investigation plan must describe how data will be collected in order to evaluate the use of the drug in children and adolescents. It also ensures that the necessary study data on children and adolescents is only collected when appropriate and that children and adolescents are not exposed to unnecessary risks.

A national catalogue of recommendations for dosing medicinal products for children (SwissPedDose) has been available to healthcare professionals in Switzerland since 2018 to the end of 2025. Further obligations and incentives to develop medicines for paediatric use have also been introduced. Their aim is to facilitate the development and accessibility of medicines for use in children. A further aim is to ensure that the medicinal products used to treat children are developed through ethically sound and high-quality research activities and are approved specifically for paediatric use. And finally, there are plans to improve the information available on the use of medicinal products in children. The intention is to achieve all these objectives without subjecting the paediatric population to unnecessary clinical trials and without delaying the approval of a medicinal product for other age groups.