Health Policy Institute

 European Digital HTA 


HTA regulation

EU HTA Regulation

Regulation 2021/2282 on health technology assessment and amending Directive 2011/24/EU life on January 12, 2022. The EU HTA Regulation will apply in January 2025 (for cancer drugs and Advanced Therapy Medicinal Products ATMPs, including gene therapies).

The HTA Regulation is the result of many (almost twenty) years of cooperation between HTA agencies from various European countries.

The regulation assumes:

  • Joint Clinical Assessment JCA
  • Joint Scientific Consultation JSC
  • Joint actions on emerging new technologies (Horizon Scanning Activities).

Currently, very intensive work is underway on the implementation of the Regulation, e.g. under the EUnetHTA21 project.
In November 2022, an online meeting of the EUnetHTA21 Stakeholder Forum was held – the presentation is available here: