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Post-Approval Surveillance

Meaning

Post-Approval Surveillance, also known as Phase IV clinical trials or pharmacovigilance, is the continuous, systematic monitoring of the safety and efficacy of a pharmaceutical product, medical device, or diagnostic tool after it has received regulatory approval and is available for widespread public use. In the hormonal health domain, this is critical for tracking the long-term safety profile of hormone replacement therapies, oral contraceptives, and novel endocrine drugs in diverse, real-world patient populations. This process is essential for detecting rare or delayed adverse events that may not have appeared in pre-market clinical trials.