Understanding the Impact of EMA’s DADI Initiative
The Digital Application Dataset Integration (DADI) initiative from the European Medicines Agency (EMA) represents a shift in regulatory expectations—from document-based submissions to structured, interoperable datasets.
DADI replaces PDF-based application forms with web-based structured data entry that feeds into the EMA’s regulatory management systems. The goal: improve data quality, ensure consistency across related documents, and enhance compatibility with downstream systems like SPOR (Substance, Product, Organisation, and Referential) and PMS (Product Management Service).
This move requires pharmaceutical companies to ensure that product-related information is not only correct—but structured and harmonized across systems and content outputs.
How Docuvera Supports DADI Readiness
Structuring Narrative into Reusable Data Points
Docuvera transforms unstructured narrative text into governed, structured components—each tagged with metadata, versioned, and ready for reuse. This allows organizations to extract and manage the same data points needed for both narrative documents (e.g., SmPC, Module 1) and structured application forms (e.g., eAF, DADI fields) without duplication or manual rework.
Alignment Between Forms and Submission Content
A common DADI challenge is maintaining alignment between structured fields and supporting text. With Docuvera, narrative content and submission data originate from the same source components—ensuring that updates made to one are instantly reflected in the other. This creates traceable consistency between eAF/DADI datasets and regulatory modules, reducing the risk of discrepancies during assessment.
Internal Harmonization of Product Data
By standardizing how data elements (e.g., dosage forms, strengths, indications) are managed and reused, Docuvera helps internal teams synchronize regulatory, labeling, and clinical documentation. This eliminates silos and reduces the risk of conflicting descriptions across submissions and regions.
Enabling Interoperability with SPOR and PMS
DADI is part of a broader regulatory ecosystem. Docuvera prepares content for integration with EMA-managed databases like SPOR and PMS by capturing structured attributes that are aligned to these schemas. This future-proofs organizational readiness for upcoming digital transformations and supports long-term compliance.
Why Structured Content Is Essential for DADI
DADI isn’t just a form redesign—it represents a foundational shift toward structured regulatory operations.
Without a structured content platform, teams are forced to reconcile narrative documents with separately maintained data fields—leading to redundancy, inconsistency, and compliance risk.
Docuvera closes this gap by serving as a single source of structured regulatory truth: one that aligns narrative text, structured fields, and submission data from the outset.
