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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
Summary
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.
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.
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