European Medicines Agency workshop on bacteriophage therapy

Workshop at the European Medicines Agency in Amsterdam, with online participation, on Friday 30 October 2026, 09:00 to 18:00 Amsterdam time (CET). It brings together regulators, policymakers, scientists, healthcare professionals, developers and patient representatives to review the regulatory landscape for phage therapy, evaluate the scientific and clinical evidence and explore how an adapted EU framework proposed by the new EU pharmaceutical legislation could be designed. In-person participation is by invitation only; online participation is by registration form. The agenda (EMA/220262/2026, Room 2A) has five sessions: opening and scene setting; scientific foundations for regulatory design, covering phage quality characterisation, EUCAST phage susceptibility testing, the draft BWP quality guideline, environmental risk and compassionate use and trial design; elements of an adapted EU framework, including platform authorisation and master files for phage libraries; international and operational perspectives (GMP, industry, FDA and TGA); and a closing synthesis. Speakers include Jean-Paul Pirnay, Tristan Ferry and Ran Nir-Paz, with regulators from EMA, the European Commission, Belgium, France, the US FDA and Australia; follow-up actions and a workshop report are planned.

In person participation is by invitation only.