New European Health Technology Assessment Regulation

In this white paper, we provide an overview of this new regulation, including key points of the new European Health Technology Assessment Regulation, its methodology, and its timelines.

HTA Regulation Background

In December 2021, the European Commission adopted the new European Health Technology Assessment Regulation, requiring clinical submissions at the European level, nearly four years after it was initially proposed in January 2018. Ultimately aimed at strengthening cooperation among European HTA agencies, the new regulation will have a progressive implementation, from 2025 to 2030.

The European Health Technology Assessment Regulation is now in place, making it mandatory for manufacturers to submit a clinical dossier at European level from 2025.

It’s important for pharma, biotech and medtech companies to be aware of this new joint assessment methodology (including type of comparators, evidence requested, and stakeholders involved) to understand the level of effort for the joint work by Member States – and what effect that has on access to new medicine.