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News

10-08-2021

DADI Project updated Questions and Answers document, Features List and project summary presentation now available

The European Medicines Regulatory Network's Digital Application Dataset Integration (DADI) Project to replace electronic application forms is pleased to announce an update of information on the project.

Within the next couple of weeks, we also aim to share an example of the variations form FHIR message based on the draft specification.

Please keep an eye on updates for the latest news on DADI. The next update will be shared in September 2021.

The Digital Application Dataset Integration Project (DADI) will replace current PDF-based electronic application forms with new web-forms.

DADI will replace the form for variations for human medicinal products first in 2022, followed by other submissions forms in 2022-2023 for centrally and nationally authorised products.

Introducing new technology for forms is a key step to optimising submissions handling processes and enabling the full use of product management services master data.

Send your questions about the DADI project to eSubProgofficer@ema.europa.eu.

DADI documentation:

17-06-2021
Following up on the initial announcement of the DADI project in March 2021 the project team has released a questions and answers document on the project.

  • DADI Questions and Answers (June 2021) New
  • The aim of the document is to provide the best available answers to questions about the project.

    • What will the DADI project do?
    • Why is DADI being started now?
    • Will DADI Deliver forms complying with veterinary Medicines regulation?

    The team aims to further release in July:

    • The timeline for the coming year, including key milestones and expected stakeholder engagement activities
    • The full list of features of the human variations form
    • Drafts of the variations form FHIR message
    Please keep an eye on updates on this portal for the latest news on DADI.

    The DADI project will replace current PDF format electronic application forms (eAFs), making the future form-filling and submission handling process more efficient. The new web-based forms will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the Fast Healthcare Interoperability Resources (FHIR) data standard. The implementation of these new forms supports the EU ISO IDMP (Identification of Medicinal Products) standards implementation for human medicines.

    DADI is part of the Telematics portfolio and supports medicines life cycle management. It incorporates the learnings and developments of the CESSP phase 1 project.

    Send your questions about the DADI project to eSubprogofficer@ema.europa.eu

    25-03-2021
    The Digital Application Dataset Integration (DADI) project will replace the current PDF-file based electronic application forms (eAFs), making the future form-filling and submission handling process more efficient. The new web-based system will be aligned with EU Implementation Guides for human and veterinary medicinal product data description, using the Fast Healthcare Interoperability Resources (FHIR) data standard, and, as a result, with the EU ISO IDMP (Identification of Medicinal Products) standards implementation for human medicines.

    DADI is part of the Telematics portfolio and supports medicines life cycle management. It incorporates the learnings and developments of the CESSP phase 1 project.

    The governance structure for DADI was established in December 2020, following the endorsement of the project charter by the EU Telematics Management Board (EU TMB). The steering group is comprised of the IT Directors Executive Committee (IT DEC) and the EMA accountable executive.

    The project plan, including relevant industry consultation steps and timelines, is under elaboration. Furthers update on the planning and timelines will be shared in due course. The variations application form (Human and Veterinary) will be the first area of focus.

    The DADI project aims to accommodate the requirements driven by Veterinary Medicines Regulation (Regulation (EU) 2019/6) implementation. We will provide a further update on the planning and timeline by May.

    Direct your questions about DADI to eSubprogofficer@ema.europa.eu
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    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

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