Abstract
The review “Post-approval changes in Labelling Regulations in the United States, Europe and Canada” goes into the details and consequences of post-approval changes in labeling regulations for pharmaceutical products. It covers the concept of post-approval changes and outlines the key areas of changes, such as various elements of product lifecycle management, market access, innovation, risk control, and legal compliance for manufacturers in the United States, Europe, and Canada. Apart from that, the abstract discusses the similarities and differences in labeling regulations across the regions in authority, structure, and the affected changes. In summary, the abstract outlines the complexities and effects of post-approval-related changes in labeling regulations concerning the pharmaceutical industry in multiple jurisdictions and the challenges encountered in implementing them. More specifically, the issues include differing regulatory frameworks and varying interpretations; operator compliance, safety evaluation and management; consolidation approaches; and the influence of digitalization and automation as a pivotal and minor player.
Published Version
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