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Public Health

Implementation of the Regulation on health technology assessment

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.

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.

HTA Stakeholder Network

The Regulation on health technology assessment (HTAR) tasks the European Commission to establish a stakeholder network through an open call for applications.

The call was published on 12 December 2022 and was open until 17:00 on 17 February 2023 (CET). The call was addressed to all eligible stakeholder organisations, in particular patient associations, consumer organisations, non-governmental organisations in the field of health, associations of health technology developers and health professionals’ organisations.

Following the assessment of the received applications, the Commission selected 45 organisations as members of the HTA Stakeholder Network and 2 organisations as observers.

Implementing acts

The European Commission is planning to adopt six implementing acts as required by the regulation, setting out rules for: 

  • joint clinical assessments
  • joint scientific consultations
  • management of conflict of interest
  • exchange of information with the European Medicines Agency (EMA). 

The first implementing act was adopted on 23 May 2023. It sets out rules for joint clinical assessments of medicinal products for human use and templates for these assessments.