The European Commission has published the presentation and recordings from its 24 April 2026 webinar for health technology developers of medicinal products, adding practical implementation material to the developing EU-level health technology assessment framework. The update does not change the legal process, but it gives developers a clearer view of how joint work is now being run and where early company action affects timelines.
The session was delivered by chairs and co-chairs of the Health Technology Assessment Coordination Group (HTACG) and its subgroups. It covered the Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) processes, HTACG guidance, access to the HTA IT Platform and the submission of early information, including letters of intent.
The materials show the framework moving from preparation to live dossier management. By March 2026, 16 JCAs for medicinal products had been initiated. Around half related to orphan-designated products and about 18% concerned advanced therapy medicinal products. The Commission also reported that the first JCA finalisation was expected soon, with further scaling anticipated on the basis of letters of intent already received.
The JSC section gives a more predictable timetable for early advice. HTACG plans to initiate eight to 12 JSCs for medicinal products in 2026, compared with five to seven in 2025. Four request periods apply in 2026, with further windows from 3 June to 1 July and from 23 September to 21 October.
The operational messages are direct. Developers are told to register early for IT platform access, submit JSC requests only within defined windows, keep letters of intent realistic and updated, and build JCA dossiers around the adopted PICO scope and HTACG templates. The Commission noted that 57% of ongoing JCAs had been delayed against the planned submission date stated in the letter of intent.
The materials reinforce the need to align regulatory, evidence-generation and market access planning earlier than under many national-only routes. Late letters of intent, incomplete clinical overviews or weak PICO mapping may now affect not only national preparation, but also EU capacity planning and the timing of the shared clinical assessment.
Source: European Commission
Link: The EU HTA Regulation: Webinar for health technology developers of medicinal products
Date: 30 April 2026
