ICH E2B(R3) defines the harmonised data and message framework used for electronic transmission of individual case safety reports.
Official resource
What the package contains
The ICH package includes the implementation guide for ICSR data elements and message specification, code lists, compatibility and mapping material, document history and questions and answers.
Practical use
Use E2B(R3) when designing, configuring, validating or troubleshooting electronic safety-reporting systems. It provides the international baseline for how ICSR information is represented and exchanged.
Regional authorities can impose additional implementation rules. For EU reporting, therefore, the ICH package should be read together with the EMA EU ICSR implementation guide and EudraVigilance business rules. Other jurisdictions may publish their own regional profiles or validation requirements.