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Swissmedic: Updating of the information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway

1 August 2026

Swissmedic: Updating of the information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway

Swissmedic has updated the information sheet "Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway". The revision takes account of the completed changeover of the reporting process via the gateway from E2B(R2) to E2B(R3) and the requirements of GVP Module VI Addendum II. Version 2.0 updates the requirements and processes for the electronic transmission of Individual Case Safety Reports (ICSRs) following the completion of the transition to E2B(R3), adds and clarifies the requirements for electronic reporting (including those concerning reporting obligations, patient identifiers, literature references, and attachments), incorporates requirements on the use of nullFlavor flags as specified in GVP Module VI Addendum II, and clarifies the organisational requirements where several marketing authorisation holders report from one pharmacovigilance database using a common sender ID. Further editorial and content-related clarifications have been made throughout. The updated information sheet comes into force on 1 August 2026.

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