Summary of product characteristics (SmPC) - Detecting and Managing Updates in SmPC
- SmPC is a Summary of Product Characteristics, it is the main structure for explaining pharmaceutical products’ characteristics in the EU.
- SmPC is a legal document used by healthcare professionals that provides information on the drug including the set dosage and other key information.
- Due to the volume of label changes per year (tens of thousands), the ability to manage these changes can do longer be managed by adding labor resources.
- Manually detecting updates can be frustrating, time consuming, and can lead to patient safety issues and regulatory challenges.