Swissmedic Guidance on ICSR Electronic Transmission

Swissmedic has released guidance for Marketing Authorization Holders (MAHs) on electronically transmitting Individual Case Safety Reports (ICSRs) in E2B(R3) format via a Business-to-Business (B2B) gateway.

Key Points:

• Technical Requirements: Outlines requirements and processes for E2B(R3) transmission, transitioning from E2B(R2).
• Scope: Covers post-authorization ICSRs for medicinal products and therapeutic biologicals in Switzerland.
• Compliance: Addresses deviations from EMA business rules, handling duplicates, and literature monitoring.
• Mandatory Transmission: Emphasizes the required electronic submission of ICSRs, including specific types, attachments, and media types.
• Data Elements: Discusses nullflavor flags, import/export processes, and references international standards (ISO, ICH, EMA).

This guide ensures compliance with the Swissmedic drug safety system and standardizes ICSR transmission.

Source: 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

Region: Switzerland