The first two joint clinical assessments for medicinal products have started under the Health Technology Assessment Regulation (EU 2021/2282). The first is for a paediatric cancer treatment and the second is for an advanced therapy medicinal product to treat skin cancer.
The joint clinical assessments are undertaken by assessors and co-assessors from competent organisations in EU Member States, as well as in Norway, Iceland and Lichtenstein.
The medicinal product for the treatment of paediatric low-grade glioma will be assessed by the National Centre for Pharmacoeconomics, Ireland, and the Institute for Quality and Efficiency in Health Care, Germany.
The advanced therapy medicinal product for the treatment of melanoma will be assessed by the National Authority for Health, France, and the Agency for Health Technology Assessment and Tariff System, Poland.
The joint clinical assessments are conducted in parallel with the marketing authorisation process, which is undertaken by the European Medicines Agency. For health technology assessments, the appointed assessors and co-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 (HTA), no later than 30 days following the adoption of a Commission decision granting a marketing authorisation for the medicinal product.
The joint clinical assessment reports produced for medicinal products and medical devices will be considered by Member States in their health technology assessment at national level, thus facilitating access pathways for patients to innovative health technologies.
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