Requirements for ICSRs reporting
The National Competent Authorities of countries where products are undergoing clinical trials or are authorised have requirements for expedited reporting of ICSRs meeting certain criteria. Increasingly, reporting of ICSRs is performed electronically via transmission of an eXtensible Markup Language (
[(ICH-E2B(R2) or ICH HL7/ISO-E2B(R3) specification].
Within the European Union (EU), there are centralised requirements for reporting ICSRs from post-authorisation sources on an expedited basis including non-serious ICSRs occurring in the EEA to the EMA’s EudraVigilance database. ICSRs must also be collated for periodic reporting of aggregate reports, signal detection and risk management.