EU Launches Joint Scientific Consultations to Enhance Health Technology Assessment

Launching Joint Scientific Consultations in 2026

The European Commission has initiated the first submission period for Joint Scientific Consultations under the EU Health Technology Assessment (HTA) Regulation. This marks the third such period following two prior rounds in 2024 that resulted in seven selected Joint Scientific Consultations, four of which are now finalized. These consultations allow health technology developers, including pharmaceutical and medtech companies, to seek guidance from Member State HTA agencies on designing clinical studies and investigations to align with requirements for future Joint Clinical Assessments (JCAs). Available at no cost, the process supports evidence generation for medicinal products, medical devices, and in-vitro diagnostic medical devices, with submissions open from January 7 to February 4, 2026, via the secure HTA IT Platform.

Aligning Studies with Assessment Needs

Joint Scientific Consultations represent a mechanism under the EU HTA Regulation (Regulation (EU) 2021/2282) to enhance coordination in health technology evaluation across Member States, focusing on the planning of clinical studies to meet evidence needs for JCAs. A key insight is the opportunity for parallel consultations with the European Medicines Agency (EMA), where meetings involve joint participation from EMA scientific advice coordinators and experts alongside HTA representatives, potentially accelerating development timelines by aligning regulatory and assessment perspectives early. For instance, developers can apply for briefing document deadlines in 2026, such as April 7, May 4, or June 8, during the initial submission window, which facilitates targeted feedback on study design to ensure robustness for subsequent JCAs. This integration not only reduces redundancy in evidence preparation but also promotes consistency in data requirements, as evidenced by the regulation’s framework that has already processed seven JSCs, demonstrating growing uptake and efficiency in the post-2025 implementation phase.

Navigating Submissions and Guidelines

The structured framework for Joint Scientific Consultations established by the EU HTA Regulation, is governed by guidelines from the Member State Coordination Group on Health Technology Assessment (HTACG), which outline rules for medicinal products, medical devices, and in-vitro diagnostics to ensure standardized procedures. Developers must submit requests using dedicated templates during designated annual periods—such as the upcoming windows from January 7 to February 4, April 1 to 29, June 3 to July 1, and September 23 to October 21 in 2026—via the secure HTA IT Platform, with early registration advised to account for access delays.

To initiate, health technology developers email the HTACG secretariat at [email protected] with a request for platform access, including contact details and an EU Login account, avoiding any commercially sensitive information in the initial correspondence; subsequent secure exchanges occur exclusively on the platform. This methodology supports the regulation’s goal of streamlining evidence for JCAs by providing scientific consultation that directly informs clinical study planning, backed by factsheets and templates that detail briefing document requirements for both standalone HTA and parallel EMA processes.

Boosting Market Access Through Harmonized Evidence

The introduction of these JSC opportunities under the EU HTA Regulation fosters harmonized evidence standards that could optimize resource allocation in clinical development and reduce variability in national HTA outcomes, ultimately influencing market access and reimbursement decisions. For health technology developers, early alignment on evidence needs through JSCs may lower the risk of post-approval assessment delays, enabling more predictable pricing strategies and value-based reimbursement negotiations across Member States, particularly for high-cost innovative therapies.