Swissmedic

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

Swissmedic updates guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway, effective 01.08.2026.

Medium impact Pharmaceuticals Health Data, Privacy & Security Switzerland pharmacovigilanceinteroperabilityhealth-data

01.08.2026

Dates and deadlines

Applies from

2026-08-01

Regulatory Deadline

August 01, 2026

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