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 blood products, establishing a framework for sharing scientific and regulatory information on development, evaluation and post-marketing surveillance of blood products. The document, dated 2 February 2026 and published by EMA on 17 July 2026, sets out objectives including achieving common understanding of each agency's regulatory approaches, providing a confidential forum for discussion of candidate blood products, and addressing new issues to harmonise views across the Atlantic.
The cluster will focus on blood products indicated mainly for haematology indications, covering clinical study design, endpoints, dosing, pharmacokinetics, safety considerations, and post-marketing monitoring. Discussions may also include manufacturing process and controls, excluding trade secret information. The primary mechanism will be teleconferences three times per year, each up to two hours, with ad-hoc meetings for pressing issues. The chair will rotate among the three agencies, and high-level minutes and action lists will be circulated for comment within three weeks.
Participants from EMA include staff from the advanced therapies and haemato-oncology office, paediatric medicines, regulatory affairs, quality, scientific advice, pharmacovigilance, and international affairs, as well as EU assessors from the Haematology Working Party. The FDA will involve colleagues from the Centre for Biologics Evaluation and Research (CBER), including the Office of Therapeutic Products, Office of Compliance and Biologics Quality, Office of Biostatistics and Pharmacovigilance, and the Office of Blood Research and Review. Health Canada will involve staff from the Biologics and Radiopharmaceuticals Drugs Directorate and the Marketed Health Products Directorate. Observers from other regulatory authorities may participate subject to agreement and confidentiality arrangements.
The cluster operates under existing bilateral confidentiality arrangements. Participants must not disclose information shared during meetings without prior authorization. The work aims to facilitate convergence and harmonisation of regulatory decisions, with topics deferred to other platforms such as paediatric or pharmacovigilance clusters when appropriate, and summaries reported back.
The cluster primarily benefits pharmaceutical companies developing blood products, who may face more consistent regulatory requirements across the EU, Canada and the US, potentially reducing duplication and accelerating market access. Patients could gain from faster availability of innovative therapies and improved safety monitoring. National regulatory authorities in EU member states may see increased alignment with international standards, though they are not directly represented. The agencies themselves will share workload and expertise, but the informal nature of the cluster means no binding commitments, limiting its direct impact on regulatory outcomes.