Post-Marketing Surveillance (PMS) refers to ongoing monitoring of a productís safety and performance after it is approved and used in broader populations.
PMS can include spontaneous adverse event reporting, registries, observational studies, and risk management activities designed to detect rare or long-term effects. PMS evidence helps identify signals not seen in controlled trials due to limited size or duration. Findings can lead to labeling updates, additional studies, or regulatory actions. Effective PMS strengthens lifecycle safety oversight and public health protection.