RegulatoryOfficial

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

🇮🇹 AIFA · Fri 30 Oct 2026

Italy's medicines agency says problems with automatic mapping of EudraVigilance ICSRs to its national network prompted a reminder on completing two key E2B(R3) fields uniformly.

The Italian Medicines Agency (AIFA) has drawn marketing authorisation holders' attention to the correct and uniform completion of two fields in individual case safety reports (ICSRs) sent under the ICH E2B(R3) standard: the medicinal product name and the active substance. The notice was published on 30 October 2026.

AIFA says the reminder follows problems it found in the automatic mapping of ICSRs coming from EudraVigilance and destined 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, so that manual mapping interventions are kept to a minimum.

AIFA adds that completion should respect the information supplied by the primary source, as well as the requirements of the ICH E2B(R3) standard and GVP Module VI. Further detail is given in a related PDF document, which was not part of the text reviewed for this article.

As general context, ICSRs are the structured case reports that feed pharmacovigilance databases, and consistent product and substance data underpin reliable processing and downstream signal detection.

What it means for your team

  • Review how medicinal product name and active substance data are populated in E2B(R3) ICSRs, including for reports from primary sources.
  • Read AIFA's accompanying PDF guidance on the two fields and compare it with current submission practice.
  • Check that completion is consistent with ICH E2B(R3) and GVP Module VI, while reflecting what the primary source reported.
  • Expect fewer manual mapping interventions at the Italian network if reports are completed correctly and can be re-routed automatically.

Official source: AIFA ↗

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

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