EMA

eSubmissions (eCTD)

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.

The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the platform. Most of these steps are independent from the eAF Portal and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems, such as Management Services for Substances, Products, Organisation and Referentials (SPOR).

For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal.

Invitation to register to the DADI eAF Training and Q&A webinars

The Digital Application Dataset Integration (DADI) Network project will replace PDF electronic application forms (eAF) used for regulatory submissions with web-forms, making the future form-filling and submission-handling process more efficient.

The variations form for Human medicinal products will be the first form to be released by DADI in October 2022. To effectively support stakeholders ahead of the go-live date, EMA is pleased to announce two new public eAF training and Q&A webinars.

  • 1st eAF training and Q&A webinar: 26 July 2022, 11:00-12:30 Central European Time (CET) - Registration link
  • 2nd eAF training and Q&A webinar: 2 September 2022, 11:00-12:30 Central European Time (CET) - Registration link

These events are training webinars for industry and national competent authorities' stakeholders wishing to learn more about access management aspects related to the new portal and the procedure to fill in a web-based eAF at go-live.

During the sessions, a demonstration focused on access management and the User Interface will be performed in order to showcase how to register and access the Portal, how to fill in the web-based eAF, select products and export the forms.

Kindly note recordings from both training sessions will be made available after each event.

Please share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu.

Recordings and documentation from the DADI public webinar held on 16th May and the System Demo held on 28th June 2022 now available

The recording from the DADI public webinar on go-live and the Quarterly system demo (Q2 2022) are now available here for the 16th May and here for the 28th of June 2022. Documentations for the webinars are also available here.