The European Medicines Agency (EMA), Health Canada, the US Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and Swissmedic have agreed on terms of reference for a cluster on advanced therapy medicinal products (ATMPs), according to a document published by EMA on 17 July 2026. The cluster aims to achieve a common understanding of each agency's regulatory approaches for ATMP development, including cell therapy, gene therapy, tissue-engineered products and xenotransplantation products, and to facilitate convergence and harmonisation of regulatory decisions.
The terms of reference, dated 23 April 2026, outline that the cluster will provide a confidential forum for exchanging draft documents, policies in development and scientific information supporting decision-making. Discussions will cover regulatory pathways, product manufacturing, clinical trial design, clinical safety evaluation, labelling and post-marketing monitoring. The primary goal is to share scientific aspects of ATMP development, evaluation and post-marketing, with the aim of aligning regulatory approaches across jurisdictions.
Participants from EMA will include staff and members of the Committee for Advanced Therapies (CAT), the Committee for Human Medicinal Products (CHMP) and the Biologics Working Party (BWP). FDA will involve colleagues from the Centre for Biologics Evaluation and Research (CBER), including the Office of Therapeutic Products. Health Canada will draw on the Biologic and Radiopharmaceutical Drugs Directorate, while PMDA will involve the Office of Cellular and Tissue-based Products and Swissmedic the Division Advanced Therapy Products.
Teleconferences are expected to occur bimonthly, lasting up to one hour, with ad-hoc meetings possible for urgent product-related assessments. The chair will rotate among the five agencies, developing the agenda and circulating minutes within three weeks. The cluster may overlap with other clusters such as the Oncology, Rare Disease and Paediatric clusters, and may invite participants from those clusters for information sharing.
The terms of reference also specify that confidentiality is covered under existing bilateral information-sharing arrangements between the members and observers. The workplan and reporting will be managed through the rotating chair, with agendas circulated at least three weeks in advance for mutual agreement.
For stakeholders, the cluster is expected to have a moderate positive impact on ATMP developers by reducing regulatory duplication and providing clearer pathways across multiple markets, potentially lowering development costs and time to approval. National regulators will benefit from shared expertise and harmonised standards, though they may face increased coordination demands. Patients could gain faster access to innovative therapies, while smaller biotech firms may find the harmonisation reduces barriers to entering multiple markets simultaneously. The cluster does not impose binding rules but aims to foster convergence, which may limit its immediate impact on regulatory divergence.