Tag: Smpc

Every approved medicine in the EU is a legal document called the Summary of Product Characteristics (SmPC). This document is critical for ensuring the safe and effective use of medicinal products, clarifying **what is the purpose of the SmPC** and why it is so important for healthcare professionals and patient safety alike.

Within European pharmacology, the acronym SPC can refer to two entirely different, yet equally vital, concepts in the pharmaceutical lifecycle: Supplementary Protection Certificates and the Summary of Product Characteristics. Context is everything when encountering this abbreviation.

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.