Today, the European Commission adopted new rules for the joint clinical assessments of medicines at Union level, contributing to faster access to medicines for EU patients. These new rules define the timelines and the steps for conducting EU joint clinical assessments. The assessment reports will provide scientific evidence to Member States’ authorities at an early stage after a medicine’s marketing authorisation. This will help them to decide about its use in the national health system, assessing their value on the basis of robust evidence, and thus taking more effective, timely decisions when bringing medicines to the market.
The rules are adopted under the Regulation on Health Technology Assessment (HTA). This Regulation established a new, innovative approach to harness and pool expertise from across the EU for assessing the effectiveness of new medicines compared to medicines already in use, while supporting healthcare systems to provide quality care for patients in the EU using the latest technologies…
