Regional and national HTA bodies provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular Member State or region.
Latest Glossary Definitions
Products selected for this pathway will have an EDC composed of the EDWP members and up to 3 additional HTABs. Once the decision to proceed with a Consolidated Parallel Consultation has been taken, the EUnetHTA ED Secretariat begins the process of recruiting additional HTABs to compose the EDC.
The Early Dialogue Committee (EDC) is constituted for a specific product and the members will fluctuate to a degree for each Consultation. In the case of Consolidated Parallel Consultations, all EDWP members and a maximum of 3 other HTA members (from EUnetHTA WP5) will participate.
The Early Dialogues Working Party (EDWP) is a standing committee established by EUnetHTA to ensure robust high-quality HTA outputs. All EDWP members will participate in procedures selected for Consolidated Parallel Consultation.
Individual Parallel Consultations are supported by the EUnetHTA ED Secretariat, thereby benefiting from HTA scientific and administrative coordination with centralised HTA recruitment, consolidated HTA comments and List of Issues, albeit with individual HTA written reports as the final product.
It refers to the parallel consultation between European Network for Health Technology Assessment (EUnetHTA) and the European Medicines Agency (
Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.
A "medical device software”, refers to a computer application that meets the legal definition of a medical device and is not a part of any distinct product.
Sponsors who are not based in the EU/EEA must appoint a legal representative based in the EU/EEA.
Adaptive pathway seeks to maximize the positive impact of new drugs on public health by balancing timely access for patients, with the need to provide adequate evolving information on benefits and risks.