On Dec 13th, 2021, the Regulation on Health Technology Assessment (HTA) has officially been adopted. The new Regulation aims to establish a system for joint clinical assessments of health technologies in the European Union. First assessments of oncologic drugs and ATMPs start in 2025, followed by orphan drugs three years later in 2028 and medicinal products for the treatment of any of the diseases referred to in point 3 of Annex I to Regulation (EC) No 726/2004 other than cancer in 2030. Click for more information>>>
Until the first assessments are carried out, the necessary governance structure and deliverables will be prepared. Together with the Institute for Quality and Efficiency in Health Care (IGWiG), the German Federal Joint Committee (G-BA) will support the implementation of the new regulation.