On 21 March 2025, the European Commission hosted a public webinar to share updates on the implementation of the EU HTA Regulation, focusing on the progress of Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs). As the EU HTA process launched on 12 January 2025, the session provided valuable insights for developers preparing to engage with the new system.
Two JCAs now underway
The first two Joint Clinical Assessments have officially entered the preparatory phase, marking a key milestone in the implementation process. These assessments are expected to align with centrally authorised products currently undergoing EMA review. A public list of ongoing JCA submissions is expected to be published alongside EMA updates to enhance transparency.
JCA and EMA timelines will run in parallel
It was confirmed that an EMA “clock-stop” — where the regulatory process pauses for applicants to respond to questions — will not trigger a pause in the JCA process. This means developers must manage JCA and EMA timelines in parallel and ensure readiness for both processes independently.
Mixed results in the first JSC submission window
The first window for Joint Scientific Consultation requests ran from 3 February to 3 March 2025. The Coordination Group received fewer applications than expected. As a result, applicants had a relatively strong chance of securing a slot. This outcome came as a surprise, particularly given concerns that the number of slots (10 for the full year) would be too limited.
Speakers suggested that the lower volume may be due to developers not yet being ready to engage in a JSC, as internal processes are still being adapted to the new system. Companies that were not selected will receive feedback outlining the reasons, and they will be permitted to resubmit in the next round.
While the submission deadline for the 2026 JSC cycle is expected in November, exact dates have not yet been confirmed. Further details from the Coordination Group are anticipated.
Evidence expectations: Addressing all PICOs
During the webinar, the Commission reiterated that health technology developers (HTDs) are expected to provide the highest level of evidence available to address each PICO outlined in the JCA scope. Several questions were raised about the implications of not addressing certain PICOs, but no formal guidance was provided. It was also restated that the number of PICOs will be consolidated to the lowest number possible.
IT platform: Practical guidance for submissions
The submission system will be hosted on a secure SharePoint platform. For security reasons, only one login email will be permitted per submission. While this may create some practical challenges for larger teams, further technical guidance is in development and will be shared in due course.
Looking ahead
The session offered helpful clarification on both procedural elements and the practical realities of early implementation. With the first JCAs progressing and lessons emerging from the initial JSC round, it’s clear that the EU HTA system is moving from design into action. However, several open questions remain — particularly around evidence expectations and the handling of incomplete PICO submissions — and developers will need to continue monitoring updates closely.
The next webinar is planned for 16 May, and a one-day conference is scheduled for 2 July (with registration expected to open in early April). It is hoped that these upcoming events will provide further clarity on the evolving EU HTA framework.