European Commission opens new window for Joint Scientific Consultations as capacity concerns continue

Health technology developers can apply for Joint Scientific Consultations from September 23 to October 21, 2026. The new request period comes amid continued discussion about whether consultation capacity can meet demand as the number of Joint Clinical Assessments grows.

The Baseline

• The fourth joint scientific consultation (JSC) request period of 2026 is open until October 21, 2026.
• Developers of medicinal products, eligible medical devices and class D in vitro diagnostics can apply for consultations scheduled from April to June 2027.
• JSCs offer an opportunity to discuss evidence needs while studies are being planned, but the number of consultations remains limited.

The European Commission has opened the fourth JSC request period of 2026. Developers have until October 21, 2026, to submit a request through the EU’s health technology assessment (HTA) IT Platform. The opportunity covers medicinal products likely to undergo a Joint Clinical Assessment (JCA), eligible class IIb and III medical devices, and class D in vitro diagnostic medical devices.

JSCs give health technology developers an opportunity to discuss the evidence likely to be needed for a future JCA while clinical development plans can still be refined, potentially helping reduce later uncertainty and improve the relevance of the evidence submitted for assessment. Like national early-advice services such as NICE Advice, they allow developers to test proposed patient populations, comparators, outcomes and study designs before pivotal studies are finalized. For medicinal products, JSCs may also take place in parallel with scientific advice from the European Medicines Agency (EMA), creating an opportunity to align regulatory and HTA expectations earlier in development.

Three consultation schedules are available in this request period. Briefing documents are due on January 11, February 8 or March 15, 2027, for discussion meetings beginning in the weeks of April 12, May 10 or June 7, 2027, respectively. These are schedules within the same application window: all requests must be uploaded by October 21, 2026.

The case for earlier advice but can capacity keep pace?

Since the EU HTA Regulation (EU HTAR) took effect in January 2025, new cancer medicines and advanced therapy medicinal products have been subject to JCA. To date, four JCA reports have been published and four assessments have been discontinued. In three of the discontinued assessments, the submitted dossiers did not meet the Regulation’s requirements, with issues concerning comparator selection, indirect comparisons and the transferability of available data.

As the first JCAs reveal gaps in submitted dossiers, early advice on evidence-generation plans is becoming increasingly relevant. Speaking at the recent RWE4Decisions symposium, Roisín Adams (National Centre for Pharmacoeconomics, Ireland), Co-Chair of the Member State Coordination Group on HTA (HTACG), described scientific consultation as a way to improve evidence-generation plans, with JSCs “crucial to fixing the downstream problems”. Earlier discussion of trial plans, she explained, could help developers understand what evidence assessors will need and build those requirements into their studies. Whether earlier consultation could have prevented any of these dossier discontinuations is subject to speculation.

Early advice is also advocated in a recent Journal of Comparative Effectiveness Research article. Ramiro Gilardino and co-authors emphasize the importance of timing: if a JSC takes place after pivotal trial protocols have been finalized or recruitment has begun, there may be little opportunity to change how evidence is generated. The consultation then risks becoming “a retroactive tracking exercise.”

Capacity, however, may limit how many developers can seek this advice early enough. In December 2024, five European industry associations warned that the number of JSCs planned for 2025 would allow only a fraction of companies preparing for JCA to discuss trial plans while changes could still be made.

The HTACG’s 2026 work program estimates that around 50 JCAs for medicinal products may be initiated in 2026, while planning to initiate 8–12 JSCs for medicinal products. Adams acknowledged that capacity remains a challenge: the HTACG is mandated to complete JCAs, while JSCs are a voluntary service for developers.

As experience with the EU HTAR grows and its processes are refined, should JSC engagement become standard practice rather than an optional pathway, as Gilardino and co-authors suggest? The proposal may receive more attention as the system develops, although how to provide advice at that scale remains to be addressed.