Harmonization of E-Labelling (Electronic Patient Information Leaflet) in Pharmaceuticals: A Global Perspective
Abstract
The shift from paper-based patient information leaflets (PILs) to electronic labeling (e-labeling) is revolutionizing the pharmaceutical industry. E-labeling provides greater accessibility, real-time updates, and better patient safety. The lack of a harmonized global e-labeling framework has, however, led to regional inconsistencies, posing difficulties for pharmaceutical firms and regulatory agencies. This article investigates the current regulatory systems in important markets like the USFDA, EMA, PMDA, and CDSCO, and also identifies differences in e-labeling standards. It focuses on standardized data formats, QR code embedment, and multilingual compatibility to maintain worldwide uniformity. A central electronic platform for e-labeling will go a long way in advancing regulatory compliance, minimizing medication mistakes, and increasing patient outcomes. Harmonization will involve coordination among regulatory bodies, pharmaceutical industries, and technology vendors to attain harmonized and efficient implementation of e-labeling systems globally.
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