The European Medicines Agency (EMA), Health Canada (HC) and the US Food and Drug Administration (FDA) have agreed on terms of reference for a joint cluster on vaccines, formalising a framework for confidential scientific exchange on vaccine development, licensure and post-marketing monitoring. The document, published by EMA on 17 July 2026, establishes objectives, participants, timing and working arrangements for the trilateral group, which aims to achieve convergent regulatory views where possible and to facilitate global discussion on novel vaccines, including those targeting emerging pathogens.
The cluster will convene via teleconference three times per year, with ad-hoc meetings as needed, and will be chaired by the three agencies on a rotating basis. Topics for discussion include regulatory pathways, pre-clinical evidence, clinical trial design (including endpoints and statistical analyses), novel approaches such as biomarkers and real-world evidence, safety evaluation, labelling, and post-marketing monitoring of vaccine safety and effectiveness. The group may also address manufacturing process and control issues, excluding trade secrets.
Participants from EMA will include staff from the Anti-infective and Vaccine, Public Health Threats Office, which will also provide the cluster secretariat, as well as members of the Emergency Task Force and assessors from the Vaccine Working Party. FDA will involve colleagues from the Center for Biologics Evaluation and Research, including the Office of Vaccines Research and Review, the Office of Biostatistics and Pharmacovigilance, and the Office of Global Policy and Strategy. Health Canada participants will come from the Biologic and Radiopharmaceutical Drugs Directorate, including the Centre for Vaccines, Clinical Trials and Biostatistics, and the Marketed Health Products Directorate.
Observers from other regulatory authorities may join subject to agreement of all three agencies and appropriate confidentiality arrangements. The cluster will generate high-level minutes and action lists, drafted by the chairing agency and circulated within three weeks. A joint bi-annual workplan will outline priorities, and a report on cluster activities will be prepared with specified frequency. The terms of reference also specify that topics may be deferred to other existing clusters, such as those on paediatric medicines or pharmacovigilance, with summaries reported back to the vaccine cluster.
The agreement does not create binding regulatory obligations but provides a confidential forum for sharing draft documents, policies in development, and scientific rationale behind each agency's decisions. The primary goal is to foster mutual understanding and, where possible, convergence on scientific and regulatory approaches to vaccine evaluation, without requiring harmonisation of standards. The cluster is expected to benefit vaccine developers by potentially reducing duplication of clinical data requirements and streamlining global development programmes, while maintaining each agency's independent decision-making authority.
Stakeholders most directly impacted include vaccine manufacturers, who may face more aligned regulatory expectations across the three regions, potentially lowering development costs and time to market. National regulatory authorities in the EU, Canada and the US will gain deeper insight into each other's scientific assessments, which could improve the consistency of safety and efficacy evaluations. Patients and public health bodies stand to benefit from faster access to novel vaccines, particularly those targeting emerging infectious diseases. However, the cluster's reliance on confidentiality and informal exchange may limit transparency for other stakeholders, such as civil society organisations, who will not have direct access to discussions or documents.