The Regulation on health technology assessment (HTAR) established the Coordination Group on Health Technology Assessment (the ‘HTACG’) composed of Member States’ representatives, mainly from HTA authorities and bodies.
The key tasks of the HTACG are to coordinate and adopt the joint HTA work carried out by its sub-groups within the scope of this Regulation and to adopt methodological and procedural guidance documents for joint work. The HTACG also aims to ensure cooperation between the relevant European Union bodies (e.g. the European Medicines Agency), as well as appropriate involvement of stakeholder organisations and experts in its work.
Members of the HTACG
The members of HTACG are designated by the Member States in accordance to Article 3(2) of the Regulation (EU) 2021/2282, following a request from the Commission. Observers from EEA countries are designated following a similar procedure.
As laid down in Article 3(8), the HTACG will provide expertise on HTA for both medicinal products and medical devices (the latter covering also in vitro diagnostic medical devices).
- Members and EEA observers of the HTACG – medical devices
- Members and EEA observers of the HTACG – medicinal products
Rules of procedure
Terms of reference for the subgroups of the Member State Coordination Group on HTA (HTACG)
- Terms of reference: Subgroup for Joint Clinical Assessments
- Terms of reference: Subgroup for Joint Scientific Consultations
- Terms of reference: Subgroup for the Identification of Emerging Health Technologies
- Terms of reference: Subgroup for the Development of Methodological and Procedural Guidance