PV Bulletin

Updated Guidance on Electronic Exchange of ICSRs in E2B(R3) Format by Swissmedic

Swissmedic has issued updated guidance confirming the transition to E2B(R3) for ICSR submissions effective August 1, 2026.

Primary source: Swissmedic

PV Impact Brief

Urgency: HighConfidence: high

What changed

The guidance specifies that MAHs must update their safety database systems to comply with the E2B(R3) specifications and verify their connections with the B2B gateway by August 1, 2026.

Why it matters

This operational change is vital for ensuring continued compliance with Swiss pharmacovigilance reporting standards and avoiding disruptions in the reporting process.

Action needed

MAHs are required to ensure their safety database systems are configured to the updated E2B(R3) specifications and verify B2B gateway connections before the August 2026 deadline.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
ICSRCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review before 2026-08-01.

Policy change details

Document type
Guideline
Policy status
effective
Publication date
2026-08-01
Coming into force
2026-08-01
Effective date
2026-08-01
Policy change
Swissmedic has released an updated version of its guidance for the electronic exchange of ICSRs using the E2B(R3) standard. This update confirms the completion of the Swiss transition to E2B(R3) and provides revised technical instructions for MAHs using the B2B gateway. The guidance is effective as of August 1, 2026.

Key changes

The updated guidance (version 2.0) includes revised technical specifications for the B2B gateway transmission of ICSRs, clarifying the requirements following the full phase-out of the E2B(R2) process. It provides updated information on connection tests and the processing of individual case reports.

Affected workflows

ICSRCountry Compliance

Responsible groups

Pharmacovigilance OperationsIT/Safety Systems

PV impact

MAHs reporting to Swissmedic must ensure their safety database systems are configured to the updated E2B(R3) specifications. PV operations teams should verify the connection with the B2B gateway and update internal reporting SOPs to reflect the finalization of the E2B(R3) transition.

View regulator source

Source document details

Exact policy details

Guidance Version
2.0
Applies to: All Marketing Authorisation Holders (MAHs)
Version: 2.0 · p. 1 · High · Source
Changeover Date for E2B(R3)
30 June 2026
Applies to: Reporting process from E2B(R2) to E2B(R3)
Swissmedic finished the changeover of the reporting process for ICSRs from E2B(R2) to E2B(R3) on the B2B gateway by 30 June 2026. · p. 1 · High · Source
ElViS E2B(R3) Update
End of 2026
Applies to: For companies not meeting B2B gateway conditions
the electronic reporting system ElViS (Electronic Vigilance System) will be updated to E2B (R3) by the end of 2026. · p. 1 · High · Source
Maximum ICSR Size
20 MB
Applies to: For ICSR submissions
The maximum total size of an ICSR is currently 20 MB. · p. 7 · High · Source
Maximum Attachment Size
15 MB
Applies to: For attachments to ICSRs
For attachments, a maximum size of 15 MB applies. · p. 7 · High · Source

Workflow rule impacts

Country Compliance | ICSRMarketing Authorisation Holders (MAHs)

MAHs must adapt to new electronic reporting format and conditions

Switch from E2B(R2) to E2B(R3) format

Swissmedic finished the changeover of the reporting process for ICSRs from E2B(R2) to E2B(R3) on the B2B gateway by 30 June 2026. · p. 1 · High · Source

Extracted documents

Primary source was weak; used same-domain rescue URL https://www.swissmedic.ch/dam/swissmedic/de/dokumente/marktueberwachung/mu/mu101_20_832_mb_guidance_for_industry_e2b_r3_gateway.pdf.download.pdf/MU101_20_832e_MB_Guidance_for_Industry_on_the_electronic_exchange_of_ICSRs_in_E2B(R3)_format_through_B2B_gateway.pdf.

Evidence and confidence

Confidence: highSource updated: Aug 1, 2026

Full briefing

Practical implication

MAHs are required to ensure their safety database systems are configured to the updated E2B(R3) specifications and verify B2B gateway connections before the August 2026 deadline.

The updated guidance provides Marketing Authorisation Holders (MAHs) with revised technical specifications for the electronic exchange of Individual Case Safety Reports (ICSRs) using the E2B(R3) standard, effective August 1, 2026. MAHs must ensure their systems are compliant with E2B(R3) and confirm connections with the B2B gateway.

What changed: The guidance specifies that MAHs must update their safety database systems to comply with the E2B(R3) specifications and verify their connections with the B2B gateway by August 1, 2026.

Why it matters: This operational change is vital for ensuring continued compliance with Swiss pharmacovigilance reporting standards and avoiding disruptions in the reporting process.

Practical implication: MAHs are required to ensure their safety database systems are configured to the updated E2B(R3) specifications and verify B2B gateway connections before the August 2026 deadline.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#Guideline#Reporting Requirement#policy-change#firecrawl-policy-agent#Swissmedic#Effective

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