Which stage occurs after regulatory approval to monitor drug safety in the general population?

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Post-market surveillance focuses on monitoring drug safety after a product is approved. Even after regulatory approval, rare side effects or long-term risks may only become apparent once the drug is used by a larger and more diverse population in real-world settings. This stage relies on pharmacovigilance activities, collecting adverse event reports, conducting observational studies, and sometimes active surveillance to detect safety signals. Findings can lead to labeling changes, usage restrictions, or withdrawal from the market. Preclinical testing, lead discovery, and clinical trials occur before approval and are aimed at establishing safety and efficacy in controlled settings, whereas post-market surveillance addresses safety in routine, real-world use.