How to prepare a JCA dossier without a detailed template?  
 

The official template as published with the Implementing Act on JCA (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202401381) is incomplete in at least two dimensions: 

❌ Guidelines are not included, even though they impact content and presentation thereof 

❌ Parts are missing, which are nevertheless relevant for consistency / understandability / scientific accuracy 

 

And the official template is only 12 pages long. For context: The empty template for the HTA dossier for Germany (AMNOG) consists of 136 pages.  

Lack of detail might provide flexibility. But structure can help avoiding problems in the first place. 

 

But: A more detailed template helps for JCA dossier preparation. You will need it for WP3.3 EU dossier outline. It creates: 

✅ Clarity for readers and authors 

✅ Reproducibility of content 

✅ Completeness of content 

✅ Consistency between different parts 

 

So a "real" template is needed for internal dossier preparation.  
 

Looking for a shortcut? Our working group here at Ecker + Ecker GmbH has produced a much more granular document for our project work. ⏩ 122 pages in total. Feel free to contact us to discuss more details about our "JCA template - Version as of August 1st, 2024". 

 

Three caveats: 

⚠ Maybe a more detailed template will be published by the Coordination Group. So watch out. 

⚠ For the time being: Align on format of presentation of information before you start writing. So prepare a template first. 

⚠ A template is only a template. Feel free to add. But do not leave out. 

 

Maybe there is some more guidance from the Coordination Group to be expected in the future. But don't rely on. 

 

🔢 This is the first part of our series "News from the EU HTA work shop". Providing you with insights from our current work on EU HTA. 

 

More on how to prepare for EU HTA in our book: EU HTA 101 

📖 Amazon (print): https://amzn.eu/d/6w1NGhn 

💻 Amazon (e-book): https://amzn.eu/d/6aZogGH