Today, the European Commission adopted a new regulation on the joint clinical evaluation of medicines at EU level, which will ensure faster access to medicines for EU patients. The new regulation defines the timetable and procedure for conducting EU joint clinical evaluations. The evaluation report provides scientific evidence to Member State authorities at an early stage after the marketing authorisation of a medicine. This will enable Member State authorities to make more effective and timely decisions when deciding whether to use a medicine in their national health systems, assess its value based on solid evidence and bring the medicine to the market.
This regulation was adopted based on the Regulation on Health Technology Assessment (HTA), which established a new and innovative approach to harnessing and pooling expertise across the EU to evaluate the effectiveness of new medicines compared to existing ones, and to support health systems in using the latest technologies to provide high-quality care to EU patients.
Commissioner for Health and Food Safety Stella Kyriakides said: “Innovation and technology are key drivers of a strong European health union and the supply of medicines to patients. We want these medical technologies to reach patients as quickly and equally as possible. Today’s adoption is a major milestone towards improving access to evidence-based healthcare and innovative technologies for patients across Europe. We need to continue working with Member States, health technology developers, patients and experts from the scientific and clinical communities to make the most of the EU’s Health Technology Assessment Framework.”
Today’s regulation is the first of six pieces of legislation to be adopted this year under the HTA Regulation: Joint clinical evaluation will begin in January 2025 for medicines containing new active substances for the treatment of cancer and advanced therapeutic medicinal products.
