In drug safety, accurate labeling is crucial in serving as the reference source for health care professionals (HCPs) to understand the appropriate use of a drug and to minimize its known risks. In the postmarketing phase, the marketing authorization holders (MAHs) have to maintain a wide range of regional labeling for a single drug and ensure the labeling information is accurate. The first available product label is usually the one on which the drug is initially approved. Since pharmaceutical companies typically submit their first application in the European Union or the U.S.A., the Summary of Product Characteristics (SmPC) or the U.S. Package Insert (USPI) are in many instances the first labels available.
In this blog, UBC’s Dr. Luca Cariolato, Sr. Safety Scientist, speaks to the importance of developing a Company Core Data Sheet (CCDS) before local safety information.