Primary reference throughout JCA procedure

🔊 On Dec 9th European Commission finally published 10 guidance documents for EU HTA. Even though publication of Implementing Acts attracted much more interest,  the guidance documents are the fine print that will decide on the details. Today we will take a closer look at the procedures around JCA (G07). Officially it is called "Procedural guidance for JCA medicinal products". 
 

This document is quite simple to read. Forget about all italics. Those are just quotes from other documents you already know. 
 

🗝️ Here are the key details not known so far: 

🔹 Assessor and co-assessor can have watchers (optional). These are members of the JCA subgroup who want to watch and learn. 

🔹 The official start of a JCA will be announced on the website. At the official start, preliminary schedules will be shared with the HTD.

🔹 Development of the assessment scope will start immediately upon submission of the application to the EMA, i.e. before confirmation of a valid submission by the EMA.

🔹 The assessment scope explaination meeting will be a virtual format, limited to 60 minutes with fixed meeting dates and no minutes or recordings. 

🔹 All content requested in the dossier template needs to be completed, including the requirements set out in the guidance G08 

🔹 The comments from the HTD during the factual accuracy check will be answered by the assessor and co-assessor, with comments and answers being published. 

🔹 Factual errors in the published JCA report can be removed.  
 

❌ What's missing? 

🔹 Any details on how confidential information will be identified and handled.

🔹 The Coordination Group explicitly refrained from providing a timeline for Type II variations. No explanation provided.