EU Health Technology Assessment Regulation 2021/2282

On 12 January 2025, Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR) became applicable, with the ambition of reshaping the evaluation of health technologies across the EU. For life sciences companies, this represents a critical moment to align strategies, ensure compliance, and seize new opportunities in an increasingly unified EU market.

Designed to harmonise health technology assessments across EU Member States, the HTA Regulation aims at ensuring that innovative treatments are evaluated consistently in the EU Single Market. Such standardisation aims to improve patient access, reduce duplicative efforts, and provide clarity to manufacturers and regulators alike.

Our comprehensive HTA Regulation Guide, developed by our life sciences regulatory team across the EU, is designed to inform life sciences companies operating in the EU about the implementation of the Regulation in the member states, and provides actionable insights to navigate these changes. The guide includes details on the current framework regulating HTA in the EU member states, and what new legislation or other steps have been taken towards implementation of the HTA locally, as well as key challenges and open questions.