Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance – Part 2: Human pharmaceutical reporting requirements for ICSR

This standard refers to individual case safety reports (ICSRs) for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that can occur from the administration of one or more human pharmaceutical products to a patient, regardless of source and destination. It seeks to create a standardised framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmitting ICSRs relating to these issues.

This standard is part 2 of 2 in Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance.