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Global trends in e-labeling: a comprehensive geographical perspective.

Agnès Dangy-Caye1, Valentin Lebreton2, Rebecca Lumsden1

  • 1Regulatory Science and Policy Europe, Sanofi (France), Gentilly, France.

Frontiers in Medicine
|December 29, 2025
PubMed
Summary
This summary is machine-generated.

Global adoption of electronic labeling (e-labeling) for medicines is progressing unevenly. While QR codes and PDF formats are common, a hybrid approach is prevalent, highlighting the need for international collaboration to harmonize e-labeling strategies.

Keywords:
EPIe-labelinge-labeling initiativee-labeling pilotelectronic product informationimplementationpaperlessregulation

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Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Affairs
  • Information Technology

Background:

  • Electronic Product Information (ePI) offers updated medicinal product details via electronic platforms.
  • ePI formats range from simple PDFs to structured HTML/XML for digitalization.

Purpose of the Study:

  • To analyze the worldwide adoption status of e-labeling for medicinal products.
  • To identify prevalent technical solutions and implementation models for e-labeling.

Main Methods:

  • Internal company survey data collected from 182 countries between January 2, 2024, and April 7, 2025.
  • Analysis of diverse implementation stages and regulatory incorporation of e-labeling.

Main Results:

  • Implementation of e-labeling varies significantly across regions, with some countries advanced and others in pilot phases.
  • A hybrid model (print + ePI) is common in pilots, but paper documentation remains mandated in most countries.
  • QR codes (74.7%) and PDF formats (67.3%) are the leading technical solutions for e-labeling implementation.

Conclusions:

  • E-labeling provides benefits like real-time updates, environmental gains, and supply chain enhancements.
  • Harmonized global adoption requires cross-regional knowledge sharing and multi-stakeholder collaboration.