The EU Joint HTA regulation was enacted in January 2022 with the primary objective of streamlining the clinical assessment process for EU member states’ HTA bodies. Given the newness of the assessment process and lack of precedent on which to draw conclusions, health technology developers such as biopharma are seeking guidance on clinical development and market access processes in this uncharted environment.

In this educational symposium, we will discuss the components of the EU joint HTA regulation, share anticipated impacts at the level of the joint and individual EU member HTA body, and provide key considerations for health technology developers as they prepare for market authorisation and HTA submission in this new and evolving process.