The Regulation (EU) 2021/2282 on health technology assessment (HTAR) entered into force on 11 January 2022 and will apply from 12 January 2025.
In the preparatory phase for the implementation of the HTAR (January 2022 – January 2025), this webpage aims at informing national authorities, health technology developers and stakeholders about the development of implementing legislation in accordance with the powers conferred to the Commission by the co-legislators.
In the implementation phase of the HTAR (beyond January 2025, when joint HTA work will start), this webpage will include all the information required by Article 30.3 of the HTAR.
- Joint Clinical Assessments
- Joint Scientific Consultations
- Factsheet on implementation of the Regulation
- Joint clinical assessment of medicinal products: Submission of early information by health technology developers
Implementation rolling plan
The rolling plan below contains a list of key activities that the European Commission has carried out or intends to carry out in preparation for the implementation of Regulation (EU) 2021/2282.
The plan is subject to regular review in order to provide national authorities, health technology developers and stakeholders with the most updated information.
Member State Coordination Group on HTA (HTACG)
The HTAR established the Coordination Group on Health Technology Assessment (the ‘HTACG’) composed of Member States’ representatives, mainly from HTA authorities and bodies. The HTACG issues guidance for the joint work, which includes joint clinical assessments and joint scientific consultations.
HTA Secretariat
The European Commission’s HTA secretariat supports the joint work led by the Member State Coordination Group on the Health Technology Assessment (HTACG).
The HTA secretariat provides administrative, technical and IT support to the Coordination Group and its subgroups, as well as to the actors taking part in joint clinical assessments and joint scientific consultations to carry out their tasks.
| The HTA secretariat can be contacted by the following e-mail addresses: | |
|---|---|
| General enquiries | SANTE-HTA ec [dot] europa [dot] eu (SANTE-HTA[at]ec[dot]europa[dot]eu) |
| Product-specific joint clinical assessments and for submission of early information for joint clinical assessments (to request access link to the HTA IT platform) | SANTE-HTA-JCAec [dot] europa [dot] eu (SANTE-HTA-JCA[at]ec[dot]europa[dot]eu) |
| Submissions of requests for joint scientific consultations (to request access link to the HTA IT platform) | SANTE-HTA-JSCec [dot] europa [dot] eu (SANTE-HTA-JSC[at]ec[dot]europa[dot]eu) |
| Technical support for the HTA IT platform | SANTE-HTA-IT-SUPPORTec [dot] europa [dot] eu (SANTE-HTA-IT-SUPPORT[at]ec[dot]europa[dot]eu) |
Please do not communicate any commercially sensitive or confidential information via e-mail.
HTA Stakeholder Network
The HTA Stakeholder Network supports the implementation of the HTAR. Its members include patient associations, associations of health technology developers, health professionals’ organisations and other non-governmental organisations in the field of health.
Implementing acts
Implementing acts set rules for joint clinical assessments, joint scientific consultations, management of conflict of interest and exchange of information with the European Medicines Agency (EMA).
- Implementing act on joint clinical assessment of medicinal products for human use
- Implementing act on exchange of information with the European Medicines Agency
- Implementing act on conflict-of-interest rules under the EU Health Technology Assessment Regulation
- Public consultation: Health technology assessment – Joint scientific consultations on medicinal products for human use
- Public consultation: Health technology assessment – Joint scientific consultations on medical devices and in-vitro diagnostic medical devices
- Implementing act on joint clinical assessment of medical devices and in-vitro diagnostic medical devices – in preparation
