The European Medicines Agency (EMA), the US Food and Drug Administration (FDA), Health Canada and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) have agreed on formal terms of reference for their international Pharmacovigilance Cluster, according to a document published by EMA on 17 July 2026. The cluster aims to exchange information on risk assessments, emerging safety concerns and anticipated regulatory actions, as well as to coordinate public communications and share views on pharmacovigilance policies and inspection findings.
The terms of reference, dated 28 January 2026, outline the cluster's goal of supporting regional risk assessment and facilitating international coordination of regulatory action. The primary mechanism will be regularly scheduled teleconferences for time-sensitive exchanges, held on Wednesdays between monthly PRAC meetings (except August), typically lasting up to two hours. Up to six topics per teleconference will be selected by mutual agreement, focusing on issues of major relevance to all agencies. Ad hoc teleconferences or in-person meetings may be organised for in-depth discussions or to identify activities of mutual benefit, such as jointly sponsored scientific symposia.
Standing members (core members) are EMA, FDA, Health Canada and PMDA, building on their long-standing collaboration under confidentiality arrangements. EMA participants include staff, PRAC (vice) chairs and rapporteurs; FDA participants come from CDER and CBER; Health Canada from the Bureau of Biologics, Radiopharmaceuticals and Self-Care Products and the Marketed Pharmaceuticals Bureau; and PMDA from the Office of Pharmacovigilance II. Teleconferences are co-chaired by EMA and FDA. Observers from other regulatory authorities may join subject to agreement of both EMA and FDA and appropriate confidentiality arrangements.
The cluster will co-develop short action points as summary records, tracked in a table. The terms of reference also allow for in-depth discussions on product-specific safety concerns, including the possibility of core members observing EMA's Pharmacovigilance Risk Assessment Committee (PRAC) or Committee for Human Medicinal Products (CHMP) discussions via telephone link.
For the pharmaceutical industry, the cluster means that safety signals and regulatory actions may be coordinated across four major jurisdictions, potentially leading to more aligned risk communication and inspection findings. This could reduce duplication for marketing authorisation holders but also require them to monitor multiple agencies' decisions more closely. National competent authorities in the EU may benefit from earlier awareness of emerging safety issues, while patients could see more consistent safety information across regions. The formalisation of the cluster may also accelerate the identification of global safety concerns, though it does not change the legal basis for national or regional decision-making.