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Bacteriophage (phage) therapy for human use is emerging as a promising tool to combat infections produced by multidrug-resistant bacteria, a growing global health threat. However, its highly personalised nature and need for strain changes does not fit easily within existing EU pharmaceutical legislation, which was developed mainly for standardised, mass-produced medicines that have a well-defined unchanged composition. While some EU Member States have introduced national mechanisms to enable patient access to unauthorised phage therapy, these approaches remain fragmented and lack a harmonised EU-wide framework.
The workshop aims to bring together regulators, policymakers, scientists, healthcare professionals, developers, and patient representatives to:
Discussions will focus on developing practical regulatory principles that balance innovation, quality, safety, and patient access, with the goal of generating recommendations that can help inform future EU delegated acts aimed at phage therapy.
To register for online participation follow use this registration form.
In person participation is by invitation only.