When Timelines Collide: How EMA Regulatory Milestones Can Impact the JCA Process, and Implications for Manufacturers and Member States

OBJECTIVES: The joint clinical assessment (JCA) is designed to facilitate timely EU access to medicines, with its timelines closely linked to those of EMA. However, the potential impact of clock stops, label changes, or new data availability on the JCA process and local assessments has not been thoroughly assessed.

Our research identified EMA regulatory process variables that could affect JCA timelines and evaluated potential impacts on health technology developers (HTDs) and member states.

METHODS: The JCA procedural implementing act, EU regulation 2011/2282 and EMA timelines were analysed to identify variables and dependencies that could alter JCA timelines. Findings were synthesized into hypothetical scenarios to identify potential deviations from the standard JCA timeline.

RESULTS: In the standard JCA procedure, HTDs receive the final scope 10 days after EMA list of questions. With an average clock stop duration, the HTD has 60/100 days to submit the dossier (accelerated/standard EMA assessments). The final JCA report is published 30 days after marketing authorization (150 days after dossier submission).

Even a short clock stop of 30 days could reduce the HTD's submission time to just 25/65 days (accelerated/standard EMA assessments). Assessment scope changes from label changes or new data could delay the JCA report by up to 18 months.

CONCLUSIONS: ‘Standard' JCA timelines rely on 'average' EMA timelines. Variability in EMA timelines could reduce dossier development time or delay final report publication. Traditionally, HTDs prefer the fastest regulatory approval route, given no significant implications of label changes. This analysis highlights the risk of a faster regulatory process/label changes, and the need for market access and regulatory teams to closely collaborate to minimize risk to both procedures. JCA assessors will need to be flexible in adapting the JCA to EMA developments, to protect dossier development time and/or avoid delays to JCA report publication, local assessments, and ultimately patient access.