What is an ICSR (individual case safety report) in pharmacovigilance?

An individual case safety report (ICSR) is the report of one patient's suspected adverse reaction to one or more medicinal products at a point in time. Under ICH E2D, a case is valid for submission once it holds four minimum elements: an identifiable patient, an identifiable reporter, at least one suspect or interacting product, and at least one adverse event or reaction. The reporting clock starts when a case meets those criteria. ICSRs are exchanged electronically in the ICH E2B(R3) format, which FDA, EMA's EudraVigilance and Japan's PMDA accept; FDA's adverse event database has been the Adverse Event Monitoring System (AEMS) since 11 March 2026, when it replaced FAERS. The sponsor's or marketing authorization holder's safety database builds and transmits the ICSR. Burna AI supplies its clinical core: the adverse event extracted from the note, graded to CTCAE, coded to a MedDRA LLT and attributed per drug with WHO-UMC and Kramer, with the source line attached.