What Is the US Equivalent of SmPC? Unpacking the US Prescribing Information
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4 min read
The United States Prescribing Information (USPI) serves a similar function to the EU's Summary of Product Characteristics (SmPC), providing vital drug information for healthcare professionals. While both documents detail a drug's approved usage, safety, and effectiveness, significant differences in format, content, and regulatory oversight mean they are not identical. This article clarifies what is the US equivalent of SmPC and explores the distinctions that affect prescribers and manufacturers alike.