The European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and Health Canada (HC) have agreed on terms of reference for a Veterinary Pharmacovigilance Cluster, according to a document published by EMA on 17 July 2026. The cluster aims to foster exchange of information on pharmacovigilance surveillance, adverse event collection and analysis, and benefit-risk assessments of specific veterinary products, with discussions held confidentially to potentially strengthen surveillance and enable earlier recognition of safety issues.
The terms of reference, dated March 2026, outline the cluster's objectives, participants, timing, working arrangements, confidentiality and reporting. Participants from EMA will come from the Pharmacovigilance Office within the Veterinary Surveillance and Regulatory Support Department; FDA participants from the Division of Pharmacovigilance and Surveillance within the Center for Veterinary Medicine's Office of Surveillance and Compliance; and HC participants from the Veterinary Drugs Directorate. Teleconferences will be chaired by the FDA and held quarterly, with agendas prepared by EMA and minutes recorded by HC. Additional ad hoc meetings may be convened for in-depth discussion of specific issues.
Confidentiality is governed by existing bilateral information-sharing arrangements between the members, and participants are prohibited from disclosing shared information without prior authorization. The cluster does not operate under a formal workplan or reporting framework; its activities are documented solely through meeting minutes and resulting actions. Other regulatory authorities, such as biologics centres, may participate subject to agreement and appropriate confidentiality arrangements.
The cluster represents a trilateral effort to harmonise approaches to veterinary pharmacovigilance across the three jurisdictions, potentially impacting veterinary drug manufacturers, animal health professionals and regulatory bodies by facilitating earlier detection of safety signals and more coordinated communication of risks. The informal nature of the cluster means no binding decisions are made, but the exchange may lead to coordinated actions when required.