Medicines for Children Research Network, Norway - NorPedMed

Medicines for Children Research Network Norway (NorPedMed) is a nationwide clinical research infrastructure for paediatric clinical trials. NorPedMed is a joint initiative of the Norwegian Directorate of Health and the Medicines for Children Network Norway. The work of NorPedMed is based on the EU pediatric regulation of January 2007, which may be viewed as a public health assignment aimed to facilitate development and availability of high quality, ethically researched and appropriately authorized medicines for children.

NorPedMed aims to strengthen the recruitment base for clinical trials in Norway and to direct research activity to the country.

NorPedMed operates on a non-profit basis and works to facilitate high-quality paediatric clinical trials in accordance with applicable regulations and Good Clinical Practice (GCP). Studies may be sponsored by industry, academia or other institutions. NorPedMed also facilitates access to relevant experts and investigators with paediatric expertise, supporting sponsors in need of such competence.

NorPedMed is not a legal entity and cannot enter into agreements. Agreements are made directly between sponsors and the relevant institutions, such as hospitals, research organisations or investigators. NorPedMed does not handle or administer study funding; this is managed by the institutions involved.

NorPedMed works to make clinical trials in Norway less time-consuming and less complex to carry out, and to improve the efficiency of the supporting infrastructure. The network can involve experts across all areas of paediatric medicine and can therefore support clinical trials across the full range of therapeutic fields in Norway. A long-term aim is to promote more harmonised processes and reduce administrative burden in clinical trials.

NorPedMed is an established and reliable paediatric trial network and has contributed to major European initiatives in this field over the past decades. It is a member of the European Network of Paediatric Research at the European Medicines Agency, Enpr-EMA).

In short, NorPedMed facilitates paediatric clinical trials in Norway through a “one-stop-shop” approach and provides the necessary infrastructure to support this.

NorPedMed is also part of NordicPedMed and will serve as the lead network in 2026–2027. This collaboration supports the conduct of clinical trials across the Nordic countries, providing access to a combined population of around 25 million. The region is characterised by well-functioning healthcare systems, high-quality registries and digitally integrated hospitals. Patients, investigators and study personnel are experienced in working within clinical research. This is particularly important for rare diseases, where access to a larger, shared recruitment base is essential.