Individual Case Safety Reports (ICSR) must be compiled for every suspected or confirmed adverse event and submitted to the Competent Authority (CA) of the Member State. They are to be submitted to EudraVigilance, in the EU.
ICSR reporting is performed electronically using the ICH ICSR format.
ICSRs should also be collated for periodic reporting requirements and signal detection.
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
If any of the basic element remains unknown then the MAH should not submit this to the competent authority but use it in other pharmacovigilance activity such as signal detection.
