UNIT 13: Literature Surveillance in Pharmacovigilance
This unit explains the role of scientific and medical literature as a critical source of safety information in Pharmacovigilance. It describes how literature is systematically monitored, reviewed, and translated into Individual Case Safety Reports to support continuous benefit–risk evaluation.
Literature surveillance is the systematic monitoring of published scientific and medical literature to identify reports of adverse events associated with medicinal products. Regulatory authorities require Marketing Authorization Holders to review literature regularly because safety information may first appear in journals before being reported through spontaneous reporting systems.
Key Points
Mandatory regulatory requirement.
Complements spontaneous reporting.
Supports early signal detection.
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