The European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and Health Canada (HC) have agreed on a new terms of reference document for their trilateral cluster on patient engagement, dated 9 February 2026. The document, published on 17 July 2026, formalises the objectives, participants, timing and working arrangements for the cluster, which aims to share best practices on involving patients throughout the medicine regulatory lifecycle.
The cluster's primary goal is to benchmark practices and policies, exchange best practices, and share information on modalities for engaging patients and their organisations within the work of the three agencies. It will also cover internal policies, guidance documents, regulations, and high-profile products or topics of mutual interest with potential high public impact. The main mechanism will be regularly scheduled teleconferences up to three times per year, each lasting up to 90 minutes, co-chaired by EMA and FDA. Ad-hoc teleconferences on product-related assessments may be held at any time.
Participants from EMA will include staff from the Public and Stakeholders Engagement Department and International Affairs, as well as therapeutic teams and EU experts as needed. FDA will involve colleagues from the Office of the Commissioner, including the Public Engagement Staff and Office of Global Policy and Strategy, and its centres CDER, CBER, and occasionally CDRH. Health Canada will involve participants from the Biologics and Radiopharmaceutical Drugs Directorate, the Pharmaceutical Drugs Directorate, and the Marketed Health Products Directorate. The teleconferences will be co-chaired by EMA and FDA.
The cluster will alternate responsibility for agenda preparation between EMA and FDA, with topics selected based on mutual interest. A draft agenda will be sent about two weeks in advance, with urgent topics added by mutual agreement. Confidentiality is covered under existing bilateral information sharing arrangements, and cluster members are prohibited from disclosing information shared during meetings without prior authorisation.
This initiative is expected to have a moderate positive impact on patients and patient organisations by potentially leading to more patient-centred regulatory decisions and improved communication. For the pharmaceutical industry, it may result in more consistent patient engagement expectations across regions, reducing duplication of efforts. However, the cluster's focus on information exchange rather than binding guidance means its direct impact on regulatory processes may be limited. The terms of reference do not specify a workplan or reporting schedule, leaving the cluster's concrete outcomes to be defined in future meetings.