Chiara Pennacchioni -

The Digital Application Dataset Integration (DADI) is a Network Project led by the EMA to transform and optimise regulatory procedure management across the product lifecycle.

The DADI Network Project will replace current interactive PDF format electronic application forms for marketing authorisation applications, variations and renewals for human medicinal products with new web-based application forms hosted on a dedicated portal and compatible with ISO IDMP (Identification of Medicinal Product) and FHIR (Fast Healthcare Interoperability Resources) standards and the EU Implementation Guide for human medicine.

The modern web-based form uses data from the SPOR (Substances, Products, Organisations and Referentials) database to provide a familiar and easy-to-read pdf in line with the Notice to Applicants requirements.

The main advantages of the new form are:

  • facilitating processes, by automating the imports of the data
  • ensuring standardised data entry, thus making forms more user-friendly for processing, validation, transmission and re-use
  • making processing more efficient, reducing errors and discrepancies
  • making systems interoperability and data sharing among regulators easier
  • simplifying operational processes (e.g., by allowing a faster opening of the PDFs and a change of versions during ongoing procedures)

The variation form for human medicinal products will be the first one to be released by DADI.

The launch date of such form is planned for October 2022, whereas its mandatory use will start in April 2023. The other forms are under consideration.

Regulatory Pharma Net is available to keep Companies currently updated on the DADI project news and to provide support for the implementation of the new web-based forms.

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