Últimas noticias
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 [...]
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 [...]
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 [...]
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 [...]
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.
Essential maintenance to PSUR and eSubmission Gateway
Please note that PSUR and eSubmission Gateway File Handler will be unavailable from Friday 12/11/2021 after 18:00, until Monday 15/11/2021 morning 8:00, due to essential maintenance. EMA gateway will, however, remain available for all communities [...]
eSubmission Gateway Web Client upgrade – Syncplicity go-live for production environment on this weekend (8th – 10th July 2022)
As previously announced, the EMA is in the process of upgrading our current Axway Gateway solution. Please note that migration of all users in the Production System will be done this weekend, starting from Friday, [...]
eSubmission Gateway Web Client upgrade – External UAT for all XCOMP users now open
The issues relating to preparations for the external UAT have been solved and all eSubmission Web Client XCOMP users are now invited to start user acceptance testing (XCOMP environment). Please refer to the Guidance on [...]
eSubmission Gateway Web Client upgrade – Migration of all (XCOMP) users to Syncplicity ongoing
The issues relating to preparations for the external UAT have been solved and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days [...]
DADI Conceptual Data Models now available
The updated excel sheet listing all fields in the Variation and Medicinal Product has been published on the DADI website on the 23rd of May. The Conceptual Data Models for the human variation form FHIR [...]
DADI Project Update
Following the news published in February 2022 on the updated timeline for the release of DADI web-based variations forms for Human medicinal products further details on the timeline leading to go-live and go-live scope are [...]
Technical issue on the eAF webpage affecting availability of the latest versions of the eAF v1.26.0.0 has been fixed
The updated versions 1.26.0.0 eAFs (Veterinary MAA and variation, human variation) were published on the eAF website on 20th of January 2022. A technical issue has been identified which means that these latest versions were [...]
DADI Project Update – Updated timeline for the release of Human variations forms
Following the announcement on the revised timeline made during the first Digital Application Dataset Integration (DADI) Network Project public webinar held on 18 January 2022, an updated timeline for the release of DADI web-based variations [...]
Veterinary Medicinal Products Regulation (Regulation (EU 2019/6) enters into force – updated eSubmission systems/forms now available for mandatory use
The use of the updated version of 1.26.0.0 eAFs is now mandatory for all new veterinary variations and marketing authorisation applications. Please note that there is no transitional period and the v1.25.0.0 cannot be used [...]
Updated versions of the eAF v1.26.0.0 now available
Updated versions 1.26.0.0 eAFs are now available on the eAF website. An updated human variation form is ready for immediate use. The change implemented in this version is a minor business rule change only and [...]