The Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment (HTA) and amending Directive 2011/24/EU is effective starting today, 11 January 2022. Click for more information>>> The Regulation aims to establish joint clinical assessments of health technologies in the European Union (EU) starting with oncologic drugs and ATMPs in 2025. Information that has been presented in the EU-HTA must not be submitted again on the national level of the member states and national HTA bodies should consider the data presented in the EU-HTA for their assessments.
Until the assessment of the first health technologies in 2025, the framework will have to be determined, including the scoping process, methodology and templates for the submission of joint scientific consultations and joint clinical assessments. Drafts for deliverables will be published within the next two years and the first public consultations are scheduled for April and May 2022. Click for more information>>>