EU Digital Application Dataset Integration (DADI) – new eAF formats

News • 01.04.2021

A new IT project called the Digital Application Dataset Integration (DADI) has been launched in the EU. The DADI project will replace the current PDF-file based electronic application forms (eAFs) with the web-based system. The new system will use the Fast Healthcare Interoperability Resources (FHIR) data standard which is the same one which is in use within the EU ISO IDMP (Identification of Medicinal Products) standards. The project will incorporate the learnings and developments of the CESSP phase 1 project. The project plan is under elaboration and further information (eg. timelines) will be shared in May. The variations application form (Human and Veterinary) will be the first area of focus.

http://esubmission.ema.europa.eu/cessp/cessp.htm