Year: 2025
Type: article
Abstract: Objective: This study analyzes and compares e-Label systems in South Korea, the United States, Europe, and Singapore following the amendment of Article 58 of the Korean Pharmaceutical Affairs Act and proposes a user-centered e-Label design.Methods: A comparative analysis was conducted on e-Label regulations in the selected regions.Key proposals include Quick Response (QR) codes for real-time regulatory information, integration into pharmacy dispensing bags, standardized visual indicators for labeling changes, an official regulatory platform for accuracy, and a QR code-based adverse event reporting system.Results: Findings indicate that QR code integration enhances information accessibility, standardized labeling improves clarity, and a centralized regulatory platform ensures accuracy.The QR code-based adverse event reporting system streamlines post-market safety monitoring.Conclusion: This study provides a comprehensive e-Label strategy to enhance information delivery and safety monitoring, fostering a patient-centered medication environment and regulatory innovation.(PeRM 2025;17:111-121)
Authors: Yu-Jeong Yang, Sun-Young Park, Sun-Young Jung
Institution: Chung-Ang University
Language: English
Subfield: Pharmacology
Domain: Life Sciences
Open Access status: hybrid
OpenAlex ID: W4408896696