🔧 PART 11: Be ready for the phase after JCA submission

Series: monthly news from the EU HTA workshop

 

🔍 JCA submission is not the finish line – it’s the start of the most intense phase. The real operational pressure begins after dossier submission.

 

You should be ready for:

➡️ Immediate technical scrutiny
After submission, the HTA Secretariat conducts a technical check. If structural issues are identified, you may have 24 hours to re-upload the full dossier.

➡️ Compressed timelines
Once requests are received, timelines tighten significantly:

🔹 ~2 weeks to address the Commission’s second request

🔹 ~1 week to respond to assessor/co-assessor clarification requests – an execution sprint instead of a review cycle!

➡️ Substantive analytical workload
Post-submission requests often go beyond minor clarifications, and you may coordinate availability across functions – in particular immediate access to statistical expertise. Requirements could be:

🔹 additional analyses

🔹 statistical quality control

🔹 rapid integration of new outputs into the dossier

 

Looking for a shortcut❓️
📋 The procedure requires proactive capacity planning, scenario anticipation, and structured cross-functional execution planning well in advance. With our experience across JCA procedures, we support teams in dossier preparation as well as in concrete planning and management of the post-submission phase. You are welcome to contact us!