Abstract 

The introduction of the EU’s Health Technology Assessment Regulation (EU-HTAR) in January 2025 marked a significant shift in how health technologies are evaluated across EU Member States. The Regulation, which established a partnership between the European Medicines Agency (EMA) and national health technology assessment (HTA) bodies, aimed to introduce a more harmonised, efficient and evidence-based assessment, addressing many of the challenges associated with the old nation-by-nation approach.

Joint clinical assessments (JCAs) offer the potential to streamline the clinical assessment process, reduce duplication of effort and shorten time to market for effective health technologies. However, the shift to a joint approach also creates new challenges, including shorter submission timelines and extensive evidence requirements for developers, and new ways of working for Member States.

The aim of this article is to raise awareness of the impact of EU-HTAR on national HTA bodies, developers and patients so far, explore what comes next and discuss how challenges in implementation can be overcome.