The EU Health Technology Assessment Regulation (HTAR), adopted in 2021, entered its first stage in January 2025, bringing oncology medicines and advanced therapy medicinal products (ATMPs) under its scope.

At the core of EU HTAR is the establishment of the joint clinical assessment (JCA), a consolidated assessment of the technology’s clinical effectiveness and safety, conducted collaboratively by representatives of EU Member States. This assessment informs the clinical evidence used in national HTA and reimbursement decisions, while each Member State will retain authority over economic evaluation and pricing decisions.