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Non serious cases: Non serious ICSRs (cases with no serious adverse drug events or reactions) are submitted to regulatory authority within 90-day timeline period.

Unexpected fatal or life-threatening suspected adverse reactions represent especially important safety information and must be reported to FDA as soon as possible but no later than 7 calendar days following the sponsor's initial receipt of the information.

Must report adverse drug experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but no later than 15 calendar days from initial receipt of the information and must submit follow-up reports within 15 calendar days of receipt of new information by the applicant.

Serious post marketing cases are reported within 15 calendar days to the NCA (national competent authorities)/HA (health authorities)...to consider it as a valid case; Identifiable patient. Identifiable reporter. The drug suspected of causing reaction/event. Adverse event or fatal outcome.

However, for the purpose of regulatory reporting, the minimum data elements for an ADR case are: an identifiable reporter, an identifiable patient, an adverse reaction, and a suspect product.

Individual Case Safety Report in the European Union For reporting purposes, done electronically in EU/EEA, the ICSR should contain the following 4 basic elements: An identifiable patient/subject; An identifiable reporter, A suspect drug or biological product, An adverse event or fatal outcome.

Description: The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products.

Individual Case Safety Report in the European Union For reporting purposes, done electronically in EU/EEA, the ICSR should contain the following 4 basic elements: An identifiable patient/subject; An identifiable reporter, A suspect drug or biological product, An adverse event or fatal outcome.