The European Union has launched its first joint clinical assessments for medicinal products under the Health Technology Assessment Regulation (EU 2021/2282). The assessments, which began on 16/04/2025, focus on two critical treatments: one for paediatric low-grade glioma and another for melanoma using an advanced therapy medicinal product.
Assessment Process
The joint clinical assessments are conducted by assessors and co-assessors from various EU Member States, including Norway, Iceland, and Liechtenstein. For the paediatric cancer treatment, the assessment is being led by the National Centre for Pharmacoeconomics in Ireland and the Institute for Quality and Efficiency in Health Care in Germany. The advanced therapy medicinal product for melanoma is being assessed by the National Authority for Health in France and the Agency for Health Technology Assessment and Tariff System in Poland.
Significance and Impact
These assessments run parallel to the marketing authorisation process managed by the European Medicines Agency. The appointed assessors will produce draft joint clinical assessment reports and summary reports, which must be endorsed by the Member State Coordination Group on Health Technology Assessment within 30 days of the Commission’s decision to grant marketing authorisation. This process aims to streamline health technology assessments at the national level, facilitating patients’ access to innovative health technologies.
Further Information
For more details on the implementation of the Health Technology Assessment regulation and the joint clinical assessments, additional resources are available, including factsheets on joint clinical assessments and information on submitting early data for these assessments. A list of ongoing joint clinical assessments is also accessible for those interested in the progress of these evaluations.
