Veterinary pharmacovigilance has evolved rapidly in recent years, shaped by new legislative requirements and a growing emphasis on proactive risk management. With the introduction of Regulation (EU) 2019/6 and the accompanying Veterinary Good Pharmacovigilance Practices (VGVP), marketing authorisation holders (MAHs) face clearer – and more demanding – expectations for how they should detect, assess, and manage safety signals related to their veterinary medicinal products (VMPs). At the same time, the European Medicines Agency (EMA) has strengthened its centralised data resources, particularly the EudraVigilance Veterinary (EVVet) system and the associated Data Warehouse. When used effectively, these tools can transform pharmacovigilance from a compliance obligation into a strategic advantage.
First, we’ll need to understand the concept of a signal. A signal is information that suggests a new or modified causal relationship between a veterinary medicinal product and an adverse event – or, in some cases, a lack of efficacy (LOE).
Signal management is structured and detailed process used to handle these signals and it includes detection, validation, prioritisation, assessment, and communication. The VGVP Signal Management module outlines this as a continuous cycle, where new data are constantly screened, emerging signals are verified and prioritised, and other validated signals feed into risk assessment and regulatory action. For MAHs, mastering this cycle is essential to maintaining compliance and ensuring animal and public health protection.
Building the Evidence: Sources and Methods
Signal detection in veterinary field relies on a combination of data sources. Reports can come directly to the MAH, through the EVVet database, or from clinical and post-authorisation studies – all contributing pieces to the bigger safety picture. Additional insights can come from the scientific literature or even data linked to product quality defects.
To identify potential signals within this massive amount of information, it is encouraged to apply both qualitative and quantitative methods. Manual review of individual case reports remains a key part – clinical evaluation is crucial for understanding the circumstances and significance of each case. Complementing this, quantitative screening techniques such as disproportionality analysis (for example, using Proportional Reporting Ratios or Reporting Odds Ratios) can help flag drug–event pairs that occur more frequently than they would be expected. However, statistical screening should always be followed by clinical validation of the cases to avoid misinterpretation due to biases or data limitations.
EVVet Data Warehouse: An Underused Asset?
A major opportunity for signal detection and management lies in the use of the EVVet Data Warehouse (DWH), part of the EMA’s EudraVigilance Veterinary system. This database brings together adverse event reports from across the EEA and in some cases, third countries, providing a broader overview than any individual company database can have. DWH allows MAH to analyse both aggregated and case-level data, supporting the identification of patterns across species and territories and helping in decision-making in signal detection phase.
Beyond its technical features, the DWH can also be useful from a practical perspective. Since regulators also use the same system, looking at DWH data can help MAH to stay on the same page with EMA methodologies and make regulatory discussions smoother. The database uses harmonised structure based on VICH standards, which makes it easier to compare data across products and markets. While its main role is regulatory, companies can get a wider view of safety trends across the EU, which is complementing their own internal data.
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Making the most of DWH in Practice
Companies should make regular EVVet analyses a routine part of their signal management activities. Depending on the product profile and associated risks, these reviews might be scheduled e.g. quarterly, although the minimum regulatory expectation is once a year. For example, a company who holds marketing authorisation for vaccine used across multiple species, might run quarterly analyses to quickly detect any unusual patterns of injection site reactions, whereas a low-risk product with only small amount of individual adverse event reports might be reviewed annually.
During the regular reviews, statistical screenings in the DWH can highlight potential signals, such as a higher-than-expected reporting rate of a particular adverse event in a specific species or region. These statistical “flags” should be followed with clinical evaluation and narrative assessment to determine the clinical relevance and causal relationship. For instance, a cluster of gastrointestinal reactions reported from the same farm or by the same veterinarian may be investigated further to understand whether it reflects the product itself, environmental factors, or for example concurrent treatments.
It is important for companies to think carefully about how DWH reviews can be integrated smoothly into internal processes. Findings from DWH analyses should be logged in the company’s signal tracking system, evaluated alongside internal case reports, and escalated to regulatory authorities when necessary. Using EMA’s data as a common evidence base not only supports thorough risk assessment but also makes communication with regulators clearer and more efficient. As the role of the DWH continues to grow, EMA has also taken steps and will provide clearer guidance on how the system should be used in practice.
Updates in the Veterinary Union Pharmacovigilance Database – Best Practice Guide
In early 2025, the draft version of the Veterinary Union Pharmacovigilance Database – Best Practice Guide (previously known as the EudraVigilance Veterinary – Best Practice Guide) was released for consultation for chapters 1 and 2. This update represents one of the most significant revisions to the guide in recent years, reflecting the maturing role of the DWH in veterinary pharmacovigilance.
One of the key additions is a new chapter titled “Practical Guidance for VGVP Module: Signal Management”. This section provides much-needed direction on how MAHs are expected to incorporate DWH data into their signal management processes. The intention is clear: regulators want to promote a consistent and transparent approach to how safety data are analysed and interpreted across the EU. The chapter explains how companies are expected to review data, which analysis methods to use, and how to report and share the results from their DWH reviews.
The final version of the guide was published on 13 November 2025, and it shows the direction regulatory authorities are taking. Previously only the access to the DWH was provided, but in the future we can be expecting clearer guidance on its practical use and support to companies in applying consistent approaches when reviewing and assessing potential safety signals. For MAHs, this means that DWH analyses are becoming an integral part of the regulatory landscape, and they should start familiarising themselves with the draft guidance and all the functionalities of the EVVet Data Warehouse, if they haven’t already done so. Establishing regular review routines, documenting outcomes clearly, and aligning internal terminology with that used in the VGVP modules will make the transition smoother once the final guide is published.
Beyond the Data: Medfiles Veterinarian’s Perspective
From a veterinarian’s perspective, signal management is much more than just a regulatory obligation or data analysis. It is like a complex puzzle made up of countless small pieces, where even the tiniest detail can be critical to seeing the full picture. Each case contributes to a deeper understanding of how veterinary medicinal products behave in the real world – across species, territories and medical conditions.
One of the most valuable resources in the veterinary signal management process is the EVVet Data Warehouse, which provides access to data from different regions and field situations. It’s a great tool that transforms everyday clinical observations into meaningful safety insights, helping protect animal health.
However, human judgment remains essential for interpreting the information gathered from the systems and identifying signals. Veterinary clinical experience plays a great role here because it provides the context needed to interpret adverse events accurately. It helps to assess each case by considering factors such as species differences, underlying conditions, treatment environments, and real-world variability.
After all, pharmacovigilance is about maintaining the delicate balance between efficacy and safety. When robust data from systems like EVVet is combined with a deep understanding of animal health, we are best equipped to ensure that medicinal products remain safe, effective, and beneficial for all animals.
Author: Saana Lamminjoki, M.Sc. Tox., Safety Manager
Saana joined Medfiles Pharmacovigilance team in May 2021 and since then has been working with both human and veterinary PV activities in the EU and UK.
Saana is responsible for operational leading of veterinary pharmacovigilance activities. Her day-to-day responsibilities for veterinary products include project management, monitoring of published scientific literature, signal detection and management, risk management and evaluation and processing of adverse event reports. Saana is also actively involved in the maintenance of the Pharmacovigilance System Master File (PSMF) and the Quality Management System related to PV, ensuring that all veterinary SOPs and processes are compliant.
Author: Vaiva Bužienė, VMD, Drug Safety Expert
Vaiva joined Medfiles Pharmacovigilance team in May 2024 and has been working with both human and veterinary PV activities in the EU and UK.
Vaiva works on global scientific literature review, signal detection and management for veterinary products and acts as a medical advisor and backup for Medfiles’ veterinary QPPVs. She also serves as the local contact person for human and veterinary PV, handling safety case reports, ensuring compliance with local regulations, and communicating with national health authorities. Her clinical experience brings valuable insight into Medfiles’ veterinary pharmacovigilance services.
See also
- Upcoming revision of the VGVP Signal Management Module: What will change in practice
- 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
