Post-Marketing Surveillance (PMS)

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.

例

• Vioxx (rofecoxib) withdrawn after cardiovascular signal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