AIFA Updates the e-Dossier Platform to Implement Regulation (EU) 2021/2282

As of 14 September 2026, an update to the eDossier platform is available, aimed at incorporating the provisions of Regulation (EU) 2021/2282 (HTA Regulation).

📌 Section A.3 – Regulatory Status of the Product
For TN-1 negotiation types, the Company must indicate whether the product is subject to a Joint Clinical Assessment (JCA). If so, the following information must be provided:
the JCA identification number;
the type of product;
the JCA status: ongoing / discontinued / adopted by the Coordination Group / published by the European Commission.

📄 Section C.3 – Description of the Evidence Supporting the Application in Terms of Efficacy and Safety
It must be specified whether additional evidence is being submitted beyond that requested by the European Commission or already assessed by the HTA Coordination Group (HTACG) and its JCA Subgroup. The characteristics of such evidence and the reasons why it should be considered at national level must also be specified.

🎯 For medicinal products subject to JCA
Completion of Sections C.4, C.5 and C.6 is not mandatory when the JCA status is “Adopted by the Coordination Group” or “Published by the EC”.
Completion of these sections remains mandatory when the JCA status is “Ongoing – prior to adoption by the Coordination Group” or “Discontinued”.

For products subject to a JCA Report, should the Company complete Section C, the information provided will be promptly shared with the Coordination Group, pursuant to Article 13(1)(e) of the HTA Regulation.

Source: https://www.aifa.gov.it/-/aggiornamento-della-piattaforma-edossier-in-attuazione-del-regolamento-ue-2021/2282