Upcoming revision of the VGVP Signal Management Module

The European Medicines Agency (EMA) published Draft Revision 1 of the Guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management on 18 September 2026. This is a substantial revision. While the current module is relatively high-level, the proposed revision provides much more detailed and practical guidance on how veterinary signal management should be performed and documented.

Greater emphasis is placed on a structured, risk-based approach throughout the signal management process, covering signal detection, prioritisation, validation, assessment, outcomes and risk minimisation. Clinical judgement and qualitative review of safety data also have a clear role throughout the process.

What are some of the key changes?

One of the most noticeable changes is the additional detail on signal detection. The revised guidance covers both quantitative and qualitative approaches, including the interpretation of disproportionality, the number of cases and reacting animals, and the use of different VeDDRA levels and groupings. It also describes specific criteria used for Signals of Disproportionate Reporting (SDRs) in EVV DWH. Importantly, signal detection should not rely on numbers alone. Clinical judgement and qualitative review of the available data remain an important part of identifying potential signals.

One terminology change concerns urgent safety issues. The former concept of an Emerging Safety Issue is replaced by Pharmacovigilance Alerts (PhV Alerts), referring to a suspected, unexpected and serious risk that may require urgent regulatory action and communication. The three-working-day reporting timeframe remains unchanged. For MAHs, this is also something to keep in mind when reviewing existing signal management procedures and terminology once the revised module is finalised.

The distinction between signal detection, validation and assessment is much clearer. Signal validation is an initial screening to determine whether there is sufficient information to justify further assessment. The aim is not to prove causality, but to decide whether the potential signal warrants further investigation.

The signal assessment section has also been significantly expanded. It includes practical considerations for evaluating case series, such as time-to-onset, dechallenge and rechallenge, alternative causes, concurrent treatments, consistency across cases, dose-response relationships and biological plausibility. There is also more emphasis on defining the risk itself, including who may be particularly at risk and under which circumstances the event occurs.

Come visit us from 10 to 13 November 2026 in Hall 23, Stand D13 to discuss veterinary pharmacovigilance with our team.