The need for early collaboration between regulators and European Union’s (EU) Health Technology Assessment (HTA) bodies when developing ‘fit-for-purpose’ evidence generation plans has long been acknowledged, and the ‘Health Technology Assessment (EU) 2021/2282’ (EU-HTAR) Regulation will be the first permanent collaboration between the European Medicines Agency (EMA) and HTA bodies in Europe. The framework for the EU-HTAR will include workstreams on joint clinical assessments (JCAs), joint scientific consultations (JSCs), the identification of emerging health technologies and the development of common HTA procedures and methodologies with a key role for the EMA planned in each case.

Indeed, the first implementing act of the EU-HTAR on JCAs carved out a key role for the EMA and proposes timelines in close synergy with the marketing authorisation (MA) process. Other implementing acts are set to be published throughout 2024 and will further define the role of the EMA through exchange of information, management of conflict of interest (draft published) and the process for JSCs, although this role is yet to be defined at the time of writing.