The European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) have agreed on terms of reference for a joint Biostatistics Cluster, a confidential forum for regulatory statisticians to exchange knowledge and harmonise approaches to medical product development. The document, published by EMA on 17 July 2026 and dated 17 June 2026, formalises a collaboration aimed at improving clinical trial design, data analysis, and regulatory guidance across the three jurisdictions.
The cluster's primary goal is to provide a platform for statisticians from the three agencies to discuss emerging biostatistics issues, with specific objectives including fostering global harmonisation, understanding scientific rationales behind differing regulatory opinions, and contributing to harmonised standards for clinical study data access and analysis. Participants include EMA staff from its Methodology workstream and International Affairs, FDA's Office of Biostatistics and Division of Biostatistics, and PMDA's Offices of New Drugs and Vaccines. Observers from other regulatory authorities may join with prior agreement and confidentiality arrangements.
Meetings are expected to be held remotely twice per year, typically in spring and fall, lasting 90 minutes, with the chair rotating among the three agencies. Agenda topics will be agreed based on importance and shared interests, with proposals circulated at least three weeks in advance. The chairing agency is responsible for scheduling, sharing materials, and leading discussions, while minutes or action points will be prepared after each meeting. Confidentiality is governed by existing bilateral information-sharing arrangements, and participants are prohibited from disclosing shared information without authorisation. Decisions will be made by consensus, defined as general verbal agreement. A joint annual or biannual workplan will be generated, and a report highlighting cluster activities will be prepared with specified frequency.
The cluster is expected to have a moderate positive impact on regulatory efficiency and consistency for pharmaceutical companies developing products for multiple markets, as harmonised statistical standards can reduce duplication and accelerate approvals. For patients, it may lead to faster access to safe and effective medicines. However, the informal, consensus-based nature of the cluster may limit its ability to resolve deep disagreements, and the confidentiality provisions could reduce transparency for external stakeholders such as academic researchers and patient advocacy groups. The initiative represents a low-key technical collaboration rather than a major policy shift, with no binding commitments or new regulatory requirements.