Questions and Answers document from the public webinar “DADI Q/A Webinar – Variations form for Human Medicinal Products Go-live” held on 12th July 2022
The Q/A document from the public webinar is now available.
The 1st DADI newsletter has been published on the EMA website
The digital application dataset integration (DADI) newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities (NCAs) in the EU updates on the progress of the DADI project.
DADI eAF Portal Guide to Registration now available
The Digital Application Dataset Integration (DADI) Network project team is pleased to announce the publication of the first version of the eAF Portal guide to registration on the DADI website
eSubmission Gateway Web Client upgrade – Migration of all (XCOMP) users to Syncplicity starting now
The preparations for the external UAT are almost finalised and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days (XCOMP environment). The link to the test system and details on how to send test submissions will be published as soon as they [...]
Recordings from the DADI public webinars held on 18th and 25th January 2022 now available
The recordings from both DADI public webinars held in January are now available here for the 18th and here for the 25th of January 2022.
Updated versions of the eAF v1.26.0.0 (bug fix version) now available
Updated versions 1.26.0.0 eAFs are now available on the eAF website. An updated human and veterinary MAA forms, Renewal form and veterinary variation form are ready for immediate use. The changes implemented in this version are minor bug fixes only and they do not affect most users. The use of the v1.26.0.0 is mandatory since [...]
Digital Application Dataset Integration (DADI) Network Project Technical Webinar (FHIR) 25/01/2022 – Presentation and the FHIR mapping and examples now available
Please find the presentation and the FHIR mapping and examples the webinar on "Common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Art57(2) and eAF". Please note that the recording from the webinar will be published as soon as it becomes available.
DADI Project updated Questions and Answers document now available
The Digital Application Dataset Integration (DADI) Network Project team is pleased to announce that an updated version of the DADI Questions and Answers documents is now available.
DADI Human Variations eAF User Acceptance Testing (UAT) – Call for Volunteers
In the context of the digitalisation of the Variations Application Form for Human Medicinal Products, the EMA is pleased to invite Applicants to participate in the UAT of the Digital Application Dataset Integration (DADI) Network project.
eSubmission Gateway Web Client – upgraded Syncplicity portal now in production
The eSubmission Web Client portal has now been upgraded to Axway Syncplicity portal. Please access the new Web Client to send submissions to the EMA here.