User-Centered e-Label Information for Enhancing Safe Use of Medicines

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.