From Case Intake to Regulatory Reporting: an Integrated Review of Individual Case Safety Report (ICSR) Management in Pharmacovigilance

Author(s)	Hari M, Thenmozhi R
Country	India
Abstract	Individual Case Safety Reports (ICSRs) form a central foundation of pharmacovigilance, converting initially reported adverse-event information into structured safety records for patient protection. Nevertheless, case processing requires a sequence of interconnected activities—including triage, data entry, medical coding, causality assessment, narrative writing, quality control, and regulatory reporting—that are frequently considered as separate activities. This review considers these stages as one connected workflow of the ICSR lifecycle and the factors affecting the reliability of safety information. It highlights the challenges of applying standard tools like MedDRA, WHO-DD, the WHO-UMC system, and the Naranjo algorithm. Additionally, it covers established approaches to duplicate detection, quality control, and electronic submission via the ICH E2B(R3) framework. Finally, it explores how artificial intelligence and natural language processing are reshaping tasks from intake to coding, balancing automation with necessary human oversight.
Keywords	Individual Case Safety Report, Pharmacovigilance, MedDRA, WHO Drug Dictionary, Causality Assessment, Medical Narrative, Quality Control, Duplicate Detection, ICH E2B(R3), Artificial Intelligence
Field	Medical / Pharmacy
Published In	Volume 8, Issue 5, September-October 2026
Published On	2026-09-13

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International Journal For Multidisciplinary Research