Presentation (CTI)

OBJECTIVES: A right to be heard means little if the clock runs out first. This study evaluated whether the procedural timelines in the JCA framework give health technology developers (HTDs) a realistic opportunity to respond to assessment requests and contribute meaningfully to the evaluation.
METHODS: A procedural and comparative policy review was undertaken using Regulation (EU) 2021/2282, Commission Implementing Regulation (EU) 2024/1381, and established European regulatory procedures. The analysis focused on response timelines for information requests, dossier preparation periods, and participation during PICO scoping. Operational requirements imposed on HTDs were compared with available response windows and established practices within EMA assessment procedures.
RESULTS: The findings identified a significant imbalance between procedural obligations and procedural opportunities. Assessment teams may request extensive additional analyses, including indirect treatment comparisons, statistical re-analyses, and evidence updates, within response windows frequently limited to approximately two weeks. Unlike EMA procedures, the JCA framework contains no stop-the-clock mechanism permitting timelines to be adjusted according to the complexity of requested work. Furthermore, manufacturers have limited influence over assessment scope determination despite being responsible for generating the evidence required to address that scope. The combined effect is a process in which participation rights exist formally but may be constrained operationally by timelines that are difficult to reconcile with the analytical tasks requested.
CONCLUSIONS: Speed and fairness need not be traded off. Complexity-based response windows and a limited stop-the-clock mechanism would protect participation and assessment quality without materially extending overall JCA timelines.