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.
What this does not cover
stated in the document's own scope- Specifies the electronic data elements and message format for ICSRs; it does not define what must be reported or by when — those are E2A/E2D and regional law.
- Covers the transmission format, not the coding dictionary used to classify events — that is MedDRA.
- Handles individual case safety reports, not aggregate periodic reports such as the PBRER/PSUR, which is ICH E2C.
- Is a messaging standard, not a pharmacovigilance quality system; the QPPV and PV system obligations sit in regional GVP.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
ICH E2B(R3) defines the data elements and the message specification for the electronic transmission of individual case safety reports (ICSRs) — the structured records of a single patient’s adverse-event case exchanged between senders and receivers such as sponsors, marketing-authorisation holders, and regulators. It specifies which data fields an ICSR contains, how they are organised, and how a case message is structured for machine-to-machine exchange, so that a report generated in one system can be received and understood in another without re-keying. E2B(R3) is built on the ISO/HL7 ICSR standard, moving the earlier E2B(R2) format onto an international messaging standard.
Scope & applicability
Electronic exchange of ICSRs between marketing authorisation holders and regulators in ICH regions. Implemented via regional guidance (EU EVWEB/gateway, FDA FAERS).
Legal basis & how it acquires force
E2B is an ICH Efficacy/pharmacovigilance guideline; the R3 data-element specification reached Step 4 in 2013. An ICH guideline is not itself law; regions implement it. The EMA mandates E2B(R3) for ICSR submission to EudraVigilance under EU pharmacovigilance legislation; the FDA supports E2B(R3) for electronic submission to FAERS; and Japan’s PMDA implements it. The obligation to report is set by each region’s pharmacovigilance law (for example EU GVP or 21 CFR 314.80); E2B(R3) supplies the harmonised electronic format in which those mandated reports are transmitted.
Document structure
| Part | Covers |
|---|---|
| ICSR message structure | The overall structure of the individual case safety report message based on the ISO/HL7 ICSR standard |
| Administrative and identification elements | Case identifiers, sender/receiver information, and report references |
| Patient and reaction data elements | Patient characteristics and the adverse reaction/event details, including MedDRA coding |
| Drug and dosage data elements | Suspect, concomitant, and interacting drugs, dosage, and indication |
| Narrative and case assessment | The case narrative, causality, and reporter information |
| Implementation and version mapping | Guidance for transmitting and mapping between E2B(R2) and E2B(R3) |
Key requirements
- 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
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.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
E2B(R3) is the transmission layer of the ICH pharmacovigilance family: E2A defines the underlying serious/unexpected concepts and timelines, E2D covers the post-approval phase, MedDRA supplies the coding terminology carried in the fields, and E2B(R3) specifies how a case is packaged and sent. Built on the ISO/HL7 ICSR standard, it underpins ICSR exchange in the EMA’s EudraVigilance and the FDA’s FAERS.
ICH E2B(R3): frequently asked questions
Quick answers to common questions about ICH E2B(R3).
What is an ICSR and what does ICH E2B(R3) do with it?
An individual case safety report is the structured record of a single patient’s adverse-event case. E2B(R3) defines the data elements it contains and the message format for transmitting it electronically between systems, so cases can be exchanged machine-to-machine.
What changed between E2B(R2) and E2B(R3)?
E2B(R3) rebuilt the ICSR format on the international ISO/HL7 ICSR standard, expanding and restructuring the data elements. It reached Step 4 in 2013 and includes guidance for mapping between the R2 and R3 formats during the transition.
Where is E2B(R3) used?
It underpins ICSR exchange in the EMA’s EudraVigilance, which mandates it under EU pharmacovigilance law, and it is supported by the FDA for electronic submission to FAERS, with Japan’s PMDA also implementing it.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.