Electronic Transmission of Individual Case Safety Reports (ICSRs)

The ICH standard defining the data elements and message specification for the electronic transmission of individual case safety reports (ICSRs). E2B(R3) is built on the ISO/HL7 ICSR standard and underpins ICSR exchange in EudraVigilance and FDA FAERS.

LAST REVISED

January 2013

PRODUCT AREAS

Pharmacovigilance

SCOPE & APPLICABILITY

Electronic exchange of ICSRs between marketing authorisation holders and regulators in ICH regions. Implemented via regional guidance (EU EVWEB/gateway, FDA FAERS).

KEY REQUIREMENTS

01Generate ICSR messages conforming to the E2B(R3) data model and regional business rules
02Maintain data quality and traceability from source case to transmitted message

IMPLEMENTATION TIPS

›Test against the specific regional gateway rules (EudraVigilance / FAERS) — schema-valid is not the same as accepted

REVISION NOTES

R3 revision built on the ISO ICSR standard, superseding E2B(R2); adopted regionally through EudraVigilance and FAERS implementations.

ICH E2B(R3): frequently asked questions

Quick answers to common questions about ICH E2B(R3).

What is ICH E2B(R3)?

ICH E2B(R3) — Electronic Transmission of Individual Case Safety Reports (ICSRs) — is a guidance issued by the International Council for Harmonisation. The ICH standard defining the data elements and message specification for the electronic transmission of individual case safety reports (ICSRs). E2B(R3) is built on the ISO/HL7 ICSR standard and underpins ICSR exchange in EudraVigilance and FDA FAERS.

Who does ICH E2B(R3) apply to?

Electronic exchange of ICSRs between marketing authorisation holders and regulators in ICH regions. Implemented via regional guidance (EU EVWEB/gateway, FDA FAERS).

What are the key requirements of ICH E2B(R3)?

ICH E2B(R3) requires, among other things: Generate ICSR messages conforming to the E2B(R3) data model and regional business rules; Maintain data quality and traceability from source case to transmitted message.

When was ICH E2B(R3) last updated?

The current version of ICH E2B(R3) dates from January 2013. R3 revision built on the ISO ICSR standard, superseding E2B(R2); adopted regionally through EudraVigilance and FAERS implementations.

RELATED STANDARDS

EU GVP Modules

EU Good Pharmacovigilance Practices (GVP)

→

21 CFR 314.80

Postmarketing Reporting of Adverse Drug Experiences

→

ICH E2A

Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

→

RELATED FDA RECALLS

where Data Integrity control fails

2026-07-15Class IICMR SURGICAL LIMITED 2026-07-15Class IIMedtronic MiniMed, Inc.2026-07-01Class IIIPG Medical Corporation

See all Data Integrity recalls →

Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.

THIS STANDARD IN PRACTICE

FDA RECALLSWhere this control failsLive recalls SPEQ maps to Data Integrity →MATURITYAssess your quality systemBaseline against this and 9 other GxP domains →FDA QMMQuality management maturityHow FDA rates the system behind this →

Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.

Weekly Briefing

Track the standards that move

When ICH E2B(R3) — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.

Read a past issue →