On Thursday 23 May, the European Commission proposed new rules for the joint clinical assessments of medicinal products at EU level, which will help to speed up access to medicines for patients in the EU.
These new rules define the deadlines and stages for carrying out joint clinical assessments in the EU. The assessment reports will provide Member State authorities with scientific evidence at an early stage following the marketing authorisation of a medicinal product. They will help them to decide on its use in the national healthcare system, by assessing its value on the basis of solid evidence, and thus make more effective and timely decisions when placing medicines on the market.
The rules are adopted as part of the regulation on health technology assessment. Joint clinical assessments will begin in January 2025 for medicinal products containing new active substances for the treatment of cancer and for advanced therapy medicinal products.
Link to the regulation in question: https://aeur.eu/f/ccf (Original version in French by Lionel Changeur)