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.
