On Friday 10 January, the European Commission announced that Regulation 2021/2282 on Health Technology Assessment will come into force on 12 January.
The text was published in the Official Journal of the EU on 22 December 2021 (see EUROPE 12843/30). During this three-year transitional period, the Commission and the Member States prepared by setting up the necessary governance structure and drafted preparatory documents to support an effective application, explains the Commission.
Initially, from 12 January, these new rules (technology assessment) will apply to applications for marketing authorisation for a new cancer medicine or an advanced therapy medicinal product (ATMP). The rules will be extended to orphan medicines in January 2028 and will cover all new medicinal products as of 2030. Selected high-risk medical devices will also be assessed as of 2026.
The rules will apply to companies seeking marketing authorisation for their products, through a new permanent European framework for health technology assessment (single submission dossier at EU level).
Link to text: https://aeur.eu/f/ezq (Original version in French by Lionel Changeur)