Definition

Standards for electronic exchange of ICSRs (e.g., ICH E2B(R3), HL7); ensure interoperability between MAHs and authorities.

Example

E2B(R3) XML submission to EudraVigilance and FDA.

Regulatory source

ICH E2B(R3), ISO IDMP, EU EV

Common mistakes

Using non-standard or legacy formats after mandate.

Inspector question

Which ICSR exchange standards do you support and for which regions?

Related terms