Summary

In summary the Regulation (Eu) 2021/2282 Of the European Parliament and of the Council of 15 December 2021 on health technology assessment (HTAR) establishes:

  • a support framework and procedures for cooperation of Member States on health technologies at Union level;
  • a mechanism by which any information for the JCA is to be submitted by the health technology developer only once at Union level;
  • common rules and methodologies for the JCA of health technologies.

 

The main parties and key procedures under the HTAR are shown in the following figure:

Figure 9: Adatpted from High Level Graph of main parties and key procedures under the HTAR. Adapted from: EU HTAR 2021/2282 – What the Harmonized HTA Will Bring, Johner Institute (2022). Available at: https://www.johner-institute.com/articles/health-care/and-more/eu-hta-regulation-2021/2282-what-the-harmonized-health-technology-assessment-will-bring/