What is "post-marketing surveillance"?

Post-marketing surveillance refers to the ongoing monitoring of a drug's safety and efficacy after it has received approval for public use and is available on the market. This process is crucial because, although pre-marketing clinical trials provide valuable information about a drug's safety and effectiveness, they typically involve a limited number of participants under controlled conditions. Once a drug is released to the general population, it may be used by diverse groups of patients in real-world settings, which can reveal different safety concerns and efficacy profiles that were not apparent during trials.

By engaging in post-marketing surveillance, regulatory agencies and pharmaceutical companies can identify and assess adverse effects, evaluate long-term efficacy, and ensure that any potential risks are communicated effectively to healthcare providers and patients. This proactive monitoring helps to maintain public health and safety by allowing for timely interventions, such as updates to labeling, warnings, or even market withdrawal if necessary. Such efforts underscore the importance of ongoing vigilance in drug safety beyond the initial approval phase.