The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have formalised a joint antivirals cluster aimed at promoting a harmonised global regulatory framework for antiviral drug development, according to terms of reference published by EMA on 17 July 2026. The cluster, agreed on 25 November 2025, provides a platform for discussing specific drug candidates, scientific advice, and confidential exchange of scientific rationale to support regulatory decisions. It covers antiviral products for HIV, respiratory viruses, viral hepatitis, herpes viruses, and emerging viral infections, including medical countermeasures.
The cluster will meet quarterly via one-hour teleconferences, chaired by the agencies on a rotational basis, with ad hoc meetings possible. Participants include EMA staff from the Vaccines and Therapies for infectious diseases office, International Affairs, and relevant committee or working party members, alongside FDA staff from the Office of Infectious Disease/Division of Antivirals. Guests from other regulatory authorities may join subject to prior agreement and confidentiality arrangements.
Confidentiality is governed by existing bilateral information-sharing arrangements, and participants are barred from disclosing shared information without authorisation. Each meeting will conclude with verbal summaries of each agency's positions. A joint annual or bi-annual workplan will outline priorities, supported by meeting minutes and actions, and a report on cluster activities will be prepared periodically.
The initiative impacts pharmaceutical companies developing antiviral drugs, who may benefit from more aligned regulatory expectations and potentially faster approvals across the EU and US. National regulatory authorities in EU member states and FDA review divisions will need to coordinate within the cluster's framework, which could reduce duplication of scientific advice. Patients may gain earlier access to novel antivirals if harmonisation streamlines development. However, the cluster's voluntary nature and confidentiality constraints may limit transparency for civil society and academic researchers seeking insight into regulatory decision-making. The terms of reference do not specify binding commitments, leaving the cluster's effectiveness dependent on sustained agency engagement.