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.
More clarity for signals under close monitoring
The expanded guidance on signals under close monitoring is particularly useful from an operational perspective.
Close monitoring may require increased pharmacovigilance activities, such as more frequent monitoring, focused searches, targeted follow-up of incoming adverse event reports or further data generation. There is also clearer guidance on timelines, reassessment and when close monitoring may be concluded or when further justification is needed.
In practice, this may help MAHs define more clearly what close monitoring actually means for an individual signal, rather than simply assigning this outcome and waiting for additional cases.
What could this mean for MAHs in practice?
Although the guideline is still under consultation, it already gives a good indication of the areas veterinary pharmacovigilance teams may want to review once the final module becomes available.
Documentation is one area that receives particular attention. Procedures should describe how the different steps of signal management are actually carried out, and documentation demonstrating that these procedures are followed should be available. This includes documented risk-based monitoring criteria, signal validations and their rationale, signal assessments and the reporting of signal management outcomes.
For MAHs, this may be a good opportunity to consider whether current signal management procedures describe the process in enough practical detail, whether there is sufficient documentation to demonstrate how the process is applied in practice, and whether terminology and processes for urgent safety issues will need to be updated.
What happens next?
The consultation is open until 18 December 2026. As the revised module is not yet final, organisations should be cautious about treating the proposed changes as new requirements. However, it gives a useful indication of where veterinary signal management guidance is heading and provides an opportunity to start considering whether existing processes may eventually need more detail or adjustment.
For veterinary pharmacovigilance professionals, the direction is encouraging: more practical guidance, clearer expectations and more detail on how signal management should work in practice.
If you need support with veterinary signal management or preparing for the revised guidance, Medfiles’ pharmacovigilance experts are happy to help. With over 15 years of experience in veterinary pharmacovigilance, our team provides a broad range of PV services that can be tailored to your specific needs.
Author:
Saana Lamminjoki, M.Sc. Tox., Safety Manager
Saana joined the Medfiles Pharmacovigilance team in May 2021 and has since gained extensive experience in veterinary PV, with responsibilities covering both EU and UK regulatory requirements.
She is responsible for the operational management of veterinary pharmacovigilance activities and acts as Deputy QPPV for a veterinary client company. Her day-to-day responsibilities include project management, scientific literature monitoring, signal detection and management, risk management, and the assessment and processing of adverse event reports.
Her role also covers the maintenance of the Pharmacovigilance System Master File (PSMF) and the PV Quality Management System, including the development and maintenance of veterinary pharmacovigilance procedures and processes to support ongoing regulatory compliance.
See also:
- What to know about veterinary signal management
- New EU veterinary GMP regulations: is your quality system clearly demonstrable
- How veterinary adverse event cases are managed in the EU/EEA and UK
- Best practices for maintaining a veterinary pharmacovigilance quality system
- Meet our people: Veterinarian brings valuable expertise to vet pharmacovigilance
- Veterinary QPPV ensures compliance with EU Regulation 2019/6
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations and pharmacovigilance of veterinary medicines
- Meet Medfiles’ dedicated animal health team – experts in CMC, regulatory affairs, pharmacovigilance and animal feed
