Data Authorisation Digital Interface (DADI)
What is DADI?
The Data Authorisation Digital Interface (DADI) is an EMA-developed digital platform that replaces PDF-based electronic Application Forms (eAFs) with structured, online forms for marketing authorisation applications (MAAs) and variations in the European Union.
DADI ensures that application data is captured as structured fields linked directly to SPOR master data domains (Substance, Product, Organisation, Referential data), enabling regulators and applicants to share accurate, consistent information without manual re-entry or document-based inefficiencies.
Why it Matters in Pharma Today
- Regulatory compliance — Meets EMA’s phased mandate to transition from PDFs to structured eAFs, supporting MAA and variation submissions.
- Data integrity — Pulls directly from authoritative master data, reducing transcription errors and inconsistencies.
- Efficiency gains — Once entered, data can be reused for future applications, avoiding duplication.
- Integration capability — APIs allow sponsor systems to push and pull data from DADI directly, streamlining authoring-to-submission workflows.
- Foundation for automation — Structured DADI data can be mapped into eCTD 4.0 submissions without manual formatting.
Global Landscape
| Region/Body | Governing Entity | Adoption Status / Timeline |
| EU | European Medicines Agency (EMA) | DADI live for certain procedures; full rollout phased by submission type. |
| EU Member States | EU Member States | Integrated with EMA systems via SPOR. |
| Outside EU | n/a | Observing DADI model; potential future adoption or adaptation. |
How DADI Works in a Component-Based Authoring Model
Enter data — Applicant populates structured fields in the DADI web interface or submits via API.
Validate — Built-in checks verify data completeness, format compliance, and SPOR alignment.
Link to content components — DADI fields can be mapped to component-based authoring templates (e.g., Module 1 administrative information).
Submit — Data transmitted to EMA and relevant NCAs in real time.
Reuse — Stored data can be re-applied to new applications, variations, or renewals without re-keying.
Typical Data Domains in DADI
- Product information — Names, strengths, pharmaceutical forms.
- Substance data — Linked to ISO IDMP standards.
- Organisation data — MAH, manufacturer, importer details.
- Referentials — Routes of administration, packaging types, regulatory procedure codes.