Étiqueté : Health Technology Assessment (HTA)
On 21 January 2025, HaDEA signed a new Framework contract to support joint clinical assessments and joint scientific consultations under Regulation (EU) 2021/2282 on Health Technology Assessment with a consortium of HTA bodies representing 21...
Under the Health Technology Assessement Regulation (EU) 2021/2028, Joint Scientific Consultation enables Health Technology Developers to exchange information on their development plans for a medicinal product or medical device and obtain guidance on the information,...
This rolling plan contains a list of key activities that the Commission has carried out or intends to carry out in preparation for the implementation of Regulation 2021/2282 on Health Technology Assessment (the “HTAR”). The...
On 12 January 2025, the Regulation on Health Technology Assessment will become applicable, bringing a significant in ensuring that innovative and effective health technologies are available to patients across the EU. The new rules create...
A video on the new rules on Health Technology Assessment has been published by the European Commission. Watch the video published by Directorate-General for Health and Food Safety on 24 January 2025.
The European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed...
The Commission Implementing Regulation (EU) 2025/117 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices has...
The basis of a Health Technology Assessment is a set of defined research questions that are to be answered by the assessment and that together define the assessment scope. In the context of the Joint...
The Member State Coordination Group on Health Technology Assessment (HTA Coordination Group), adopted this guidance pursuant to Article 3 (7), in combination with Article 17(3) of the Health Technology Assessment Regulation (Regulation (EU) 2021/2282). The...
The Outcome document for Joint Scientific Consultations on Medicinal Products has been adopted on 28 November 2024 by the HTACG pursuant to Article 3(7), point (d), of Regulation (EU) 2021/2282 on Health Technology Assessment. According...