RegulatoryOfficial

AIFA urges MAHs to fix medicinal product and substance fields in E2B(R3) ICSRs

🇮🇹 AIFA · Fri 30 Oct 2026

Italy's medicines agency says problems with automatic mapping of EudraVigilance cases to its national network prompted a reminder on how to complete product name and active substance fields.

The Italian Medicines Agency (AIFA) has reminded marketing authorisation holders to complete the medicinal product name and active substance fields consistently and correctly in individual case safety reports (ICSRs) sent in the ICH E2B(R3) format. The notice was published on 30 October 2026.

AIFA says the reminder follows difficulties it found in the automatic mapping of ICSRs that come from EudraVigilance and are meant for the Italian National Pharmacovigilance Network (Rete Nazionale di Farmacovigilanza, RNF).

The agency's stated aim is to ensure medicines and active substances are identified correctly. It also wants to support automatic acquisition of reports through re-routing, which would reduce the amount of manual mapping needed. It adds that this should respect the information supplied by the primary source, the requirements of the ICH E2B(R3) standard and GVP Module VI.

The detailed instructions are in a separate 0.65 MB PDF document linked to the notice. The web page itself gives only a short description and does not set out the specific rules.

What it means for your team

  • Pharmacovigilance teams should check how product name and active substance data are populated in E2B(R3) ICSRs sent through EudraVigilance, especially for cases routed to Italy.
  • Read AIFA's linked PDF guidance and compare it with current case-entry conventions and any MAH-side mapping or data-cleaning rules.
  • Inconsistent entries can force manual mapping at the RNF, so MAHs should expect the agency to look at this area.

Official source: AIFA ↗

Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.

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