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Why Docuvera > Current/Future Standards

Structured Labeling & Product Information

FDA SPL, ePI, EMA DADI, HL7 FHIR

Powering Consistent, Compliant Content from Core Data to Patient-Facing Formats

Global health authorities are evolving their expectations for how product information is created, reviewed, and distributed. Initiatives such as ePI (electronic Product Information), FDA SPL, and EMA’s DADI aim to replace disconnected document files with modular, metadata-driven content that is accessible, machine-readable, and compliant by design.

Docuvera enables life sciences organizations to transform regulatory labeling and product information into structured, multichannel-ready content—with full traceability across affiliates, submissions, and product variants.

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Supporting Standards for the U.S., E.U. & Across the Globe

IFDA SPL & HL7 FHIR Compatibility

In the U.S., Structured Product Labeling (SPL) is a foundational format for submitting and maintaining labeling content in XML. Docuvera enables upstream structured authoring that aligns with SPL content architecture:

Modular components mapped to SPL sections (e.g., Indications, Dosage, Adverse Events)
Metadata controls to support indexing, labeling history, and safety integration
Compatibility with downstream SPL tools and publishing systems

As the FDA explores FHIR for labeling interoperability, Docuvera’s structured architecture supports content reuse in FHIR-convertible formats.

Structured Authoring for Labeling Operations

Labeling content must reflect source truth across regulatory, medical, and safety functions. Docuvera allows teams to author, manage, and update:

Core Data Sheets (CDS/CCDS)
Package inserts and SmPCs
Regional and language variants
HCP and patient-facing versions

Each component is governed, versioned, and metadata-tagged—enabling reuse across markets, channels, and regulatory filings.

ePI (Electronic Product Information) for EU Readiness

The EMA’s electronic Product Information (ePI) initiative is transforming SmPCs and PLs into structured, digitally navigable formats. Docuvera supports ePI readiness through:

Structured, language-neutral content components
Regional and product-level variant management
Multichannel outputs for human-readable and machine-readable formats
Full traceability across versions and translations

Dive deeper into ePI

Managing Global Labeling at Scale

For multinational pharmaceutical organizations, managing global labeling involves reconciling:

Affiliate-level variations
Product lifecycle changes
Regulatory and safety updates

Docuvera simplifies this complexity by providing:

A single source of truth for all structured labeling content
Role-based access and change control
Automated impact analysis for updates across global submissions

EMA DADI Integration for Variation Applications

The Digital Application Dataset Integration (DADI) initiative from EMA requires structured datasets to accompany variation forms—replacing free-text entries and document uploads.
Docuvera aligns narrative labeling content with DADI-linked fields through:

Component-level metadata tagging
Controlled content branching across product variants and markets
Structured content that supports synchronization with digital application platforms

Dive deeper into DADI

Related Standards & Initiatives Supported by Docuvera

FDA SPL (Structured Product Labeling)

Region

U.S.

Purpose

XML-based labeling format for product submissions

Docuvera Alignment

Authors modular content compatible with SPL architecture

HL7 FHIR for Labeling

Region

U.S. / Global

Purpose

Enables digital interoperability of health content

Docuvera Alignment

Structured content blocks support mapping to FHIR outputs

ePI (Electronic Product Information)

Region

EU (EMA)

Purpose

Digital SmPC and PL formats for patients and HCPs

Docuvera Alignment

Enables modular authoring and variant management for machine-readable output

DADI

Region

Global

Purpose

Structured dataset model for variation and submission forms

Docuvera Alignment

Metadata-rich content aligns with structured digital application fields

Global Labeling Lifecycle Management

Region

Global

Purpose

Harmonize regulatory labeling across products, regions, and platforms

Docuvera Alignment

Provides end-to-end traceability, reuse, and change control

Business Impact

Organizations using structured content for labeling and product information realize:

Significant reduction in manual updates across affiliates
Improved compliance with global regulations (FDA SPL, EMA ePI, DADI)
Accelerated submission cycles due to modular reuse and version control
Multichannel readiness across regulatory, digital, and patient access platforms

Related Content:

ePI
Digital Transformation in Pharma
Regulatory Compliance & Risk Mitigation
Enterprise Governance

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