Post-Marketing Surveillance (PMS)

PMS

Regulatory

The practice of monitoring the safety and efficacy of a pharmaceutical product after it has been approved and released to the general market. Detects rare adverse events, long-term effects, and drug interactions not identified in clinical trials due to limited sample sizes and durations. Includes spontaneous reporting systems (e.g., FDA FAERS, EMA EudraVigilance), registries, and mandated Phase IV studies.

Примеры

Vioxx (rofecoxib) withdrawn after cardiovascular signal
FDA MedWatch spontaneous reporting system
Thalidomide birth defect detection in the 1960s

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The practice of monitoring the safety and efficacy of a pharmaceutical product after it has been approved and released to the general market. Detects rare adverse events, long-term effects, and …