When a company reports an adverse event to a health authority or a partner, both sides need to read the report in the same way. ICH E2B is the international standard that makes this possible: it defines the data elements of an Individual Case Safety Report (ICSR) and the electronic format used to exchange it.
What changed with R3
E2B (R3) is the current revision of the standard. Reports are exchanged as structured XML messages, with more detailed and more consistent data fields than the earlier R2 format. This makes cases easier to exchange between systems, to search and to analyse.
For a safety team, this means more of the case is captured as structured, coded data, and less as free text. It also means your safety database must be able to create, validate and export R3 files reliably.
What to look for in a safety database
A database built for E2B (R3) should guide users through the required fields, validate each case against the standard before submission and produce the XML file without manual editing. It should also be validated and keep a full audit trail.
Vigipx, Insight’s safety database, was built around E2B (R3) from the start and is used by most pharmacovigilance teams in Egypt.