The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have agreed on terms of reference for quarterly bilateral videoconferences on veterinary medicinal products, as outlined in a document published by EMA on 17 July 2026. The cluster aims to foster international cooperation, exchange scientific information, and coordinate on antimicrobial resistance and harmonisation activities.
The terms of reference, dated February 2026, define the objectives, participants, timing, working arrangements, confidentiality, decision-making, and reporting for the meetings. The primary goal is to facilitate information exchange on veterinary medicinal products and achieve greater international cooperation. Specific objectives include promoting parallel scientific advice, enhancing cooperation on antimicrobial resistance and VICH activities, and coordinating existing clusters on pharmacovigilance and novel therapies.
EMA participants will include management and experts from its Veterinary Medicines Division, while FDA participants will represent the Center for Veterinary Medicine (CVM), including offices for new animal drug evaluation, surveillance, compliance, minor use, and applied science. Meetings will be chaired alternately by EMA and FDA. Agendas will be prepared by EMA, and high-level minutes will be recorded by FDA and agreed at the following meeting. Ad hoc meetings may be arranged for in-depth discussions on specific issues.
Confidentiality is governed by existing bilateral information-sharing arrangements, and decisions will be reached by consensus. The cluster's priorities and progress will be documented in meeting agendas and minutes. The terms of reference formalise a collaborative platform that has been operating, aiming to streamline regulatory processes and improve the scientific basis for decision-making on veterinary medicines.
Stakeholders impacted include veterinary pharmaceutical companies, which may benefit from more aligned regulatory expectations and potentially faster approvals through parallel scientific advice. National regulatory authorities in the EU and US could see enhanced cooperation and information sharing, reducing duplication of efforts. Animal health professionals and livestock producers may gain from improved access to innovative veterinary products. However, the cluster's focus on confidentiality and limited public reporting may reduce transparency for civil society and consumer groups concerned about antimicrobial resistance and animal welfare.