The EU HTA Regulation, Regulation (EU) 2021/2282 on health technology assessment, became applicable on Sunday 12 January 2025. From that date, a marketing authorisation application for a new cancer medicine or an advanced therapy medicinal product (ATMP) that is validated by the European Medicines Agency triggers a joint clinical assessment carried out at EU level, according to the European Commission's announcement of 10 January.
The regulation was adopted in December 2021 and entered into force in January 2022. The three years since then were used to set up the governance structure, adopt implementing and delegated acts and prepare methodological guidance. The new framework replaces the long-standing, project-based cooperation between Member States on health technology assessment that had been funded by the EU.
How joint clinical assessments work
Under the EU HTA Regulation, a Member State Coordination Group made up of national HTA bodies, working through subgroups, jointly assesses the relative clinical effectiveness and relative clinical safety of a new technology compared with existing ones. Developers file a single EU-level submission file instead of parallel national dossiers, and the Commission says the assessments are to be completed within 30 days after the medicine is authorised. Patients and clinicians are to be consulted systematically while reports are prepared.
The Commission's questions and answers stress that the joint work is clinical only. Member States must give due consideration to a joint clinical assessment report and annex it to their national HTA report, but they may add their own clinical analyses and non-clinical work such as budget impact or cost-effectiveness. Conclusions on overall value, and pricing and reimbursement decisions, remain national. HTA bodies may also run joint scientific consultations to advise developers on clinical study design.
Who is affected and when
The scope is being phased in. Oncology medicines and ATMPs come first from 12 January 2025. Selected high-risk medical devices are due to be assessed from 2026, orphan medicinal products join in January 2028, and from 2030 the rules will cover all new medicinal products seeking centralised authorisation.
For developers, the practical change is that clinical evidence planning for EU launches now has to anticipate a single EU assessment running alongside the regulatory review, with comparators and outcomes framed for many national systems at once. National HTA bodies, in turn, must report to the Commission within two years of the date of application on how joint work has been considered in their own processes.
