The New Regulation on Health Technology Assessment in the European Union
May 20, 2022
In January 2022, the new Regulation (EU) 2021/2282 of the European Parliament and the Council of the European Union of 15 December 2021 on health technology assessment (the “HTA Regulation”) entered into force on the territory of the European Union. The HTA Regulation aims to harmonize (but not to fully centralize) the currently fragmented procedure for assessing the health technologies of innovative medical therapies entering the European Union market in different European countries. The HTA Regulation shall begin to apply in stages from 12 January 2025 and the European Commission has already approved an implementation plan until that date, which includes mainly the establishment of the information resources needed for its operation, the creation of new supranational bodies to participate in the application of the Regulation and training of the competent national authorities.