The European Commission has published its first joint clinical assessment report under new EU rules for evaluating health technologies, covering the cancer medicine Ojemda (tovorafenib).
Joint clinical assessments are designed to let EU countries work together to review the clinical benefits and risks of certain new medicines and medical devices, rather than carrying out separate national assessments, the Commission noted in a release on Tuesday.
The first report was endorsed by all EU member states and examines the relative effectiveness and safety of Ojemda, an orphan medicine for paediatric low-grade glioma, the most common type of brain tumour in children.
Ojemda received a one-year conditional marketing authorisation from the Commission on 20 April 2026, following a scientific assessment by the European Medicines Agency.
New EU framework started in 2025
The joint clinical assessment was produced under the EU Health Technology Assessment (HTA) Regulation, which began applying in January 2025, the Commission said.
Since then, 18 joint clinical assessments have been initiated for new cancer medicines and advanced therapy medicinal products.
Health commissioner Olivér Várhelyi said the reports are intended to provide “high-quality scientific assessments” to member states and support national decisions on whether to make new treatments available, as well as pricing and reimbursement processes.
Further joint clinical assessment reports are due to be completed and published in the coming months.
