Passing a Camel Through the Eye of a Needle: How Flexible Will the EU Joint Clinical Assessment Process Need to be to Fit the Time Available

OBJECTIVES: The EU-HTA Regulation requires the production of Joint Clinical Assessments (JCA) in parallel to the EMA Regulatory process. Whilst the EMA process is well defined, some steps are of variable length. This study examines the impact of variable EMA durations on the planned JCA timeline.

METHODS: Process steps for developing a JCA report were reviewed in the EU-HTA Regulation (EU)2021/2282, accompanying Implementing Act (EU)2024/1381 (IA), and EUnetHTA21 deliverable D5.4. Published data on EMA procedural timelines were also reviewed. The relationship between planned JCA durations and observed EMA timelines were compared.

RESULTS: The EMA centralised procedure takes 210 days. Adding two clock stops, where Health Technology Developers (HTD) respond to questions, increases this duration by an average 90 and 30 days respectively. The European Commission then has 67 days to adopt the Market Authorisation, resulting in a total of approximately 400 days. For the accelerated procedure, the total is approximately 280 days.

The IA allocates 130 days to the JCA scoping process. HTDs then have 100 days to develop their dossier. This provides assessors with 200 days (30 days after approval) for assessor activities: assessment, drafting, reviews, editing and approving the JCA report, aligning with the planned EUnetHTA21 timeline.

However, shorter first clock-stops of 1 month do occur. In this situation, the Regulation requirement of submission ‘45 days prior to CHMP opinion’ reduces HTD writing time to 65 days, and the assessors lose between 35 and 65 days of their allocated assessment time. For the Accelerated procedure assessors may lose between 30 and 50 days from planned allocation.

CONCLUSIONS: Where the first Regulatory clock stop is short, or the accelerated procedure is followed, it is recognised HTDs will have less time to write their submission. This review also demonstrates that assessors may have significantly less time than planned to conduct their required activities.