The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have agreed on terms of reference for a new cluster focused on non-clinical oncology, aiming to share best practices and seek alignment on regulatory science aspects of oncology product development. The cluster, formalised in a document dated 17 July 2026, will primarily discuss non-clinical aspects of products under marketing review and at the investigational stage, covering drugs and biologicals within the scope of ICH S9 and its Q&A. The initiative is expected to benefit pharmaceutical companies developing oncology products by potentially reducing duplicative non-clinical testing, while regulators gain from harmonised review approaches. However, the cluster's recommendations are explicitly non-binding and consultative, meaning any alignment achieved will depend on voluntary adoption by each agency.
The cluster will convene via teleconference three times per year, with ad-hoc meetings possible for pressing product-related assessments. Participants from the FDA will include non-clinical reviewers, team leads, and supervisors from the Division of Hematology Oncology Toxicology within the Office of Oncologic Diseases; EMA participants will include members of the Non-clinical Working Party and staff from the Translational Sciences office. The meetings will be co-chaired by both agencies, with agendas prepared on a rotating basis. Confidentiality is governed by existing bilateral information-sharing arrangements, and discussions are intended to promote the 3Rs principles (replacement, reduction, refinement) in animal testing. The cluster's work may lead to more efficient non-clinical development pathways, potentially lowering costs for drug developers and accelerating patient access to new oncology therapies, but also risks creating additional informal expectations that could increase regulatory burden if agencies later reference cluster discussions in reviews.