As part of the Joint Action 3 (JA3) running from 2016 to 2020, the EUnetHTA collaboration recently published a call for expression of interest in the establishment of new multi-HTA Early Dialogues (EDs) for pharmaceuticals. Launched within the framework of the Work Package 5 (WP5) that is dedicated to improving evidence generation, this new initiative aims to address the differences in HTA methodology and to increase sponsors’ awareness of differences in evidence requirements from various national HTA bodies across the EU. This should also facilitate patient access to new medicinal products.
In practical terms, the EUnetHTA offers to organise Early Dialogues either with HTA bodies, or in parallel between regulators and HTA bodies, for new drugs or existing drugs with a new indication, and with a priority to products intended to treat severe conditions.
The call for expression of interest, for which you can find the detailed information here, is open to all interested drug developers and sponsors. A total of 13-15 Early Dialogues are expected to be organised.