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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

Exploring new ways to fight antimicrobial resistance

The European Medicines Agency (EMA) will host a workshop on the use of bacteriophages to treat bacterial infections on 8 June 2015. The workshop will be broadcast live on EMA’s website and will provide a platform for experts from academia, industry, regulatory bodies to discuss key issues related to the potential therapeutic use of bacteriophages as anti-bacterial agents. For more information, please see the agenda of the workshop.

The emergence of bacteria that are resistant to most, if not all, currently available antibiotics is a major threat to public health. The development of alternative anti-bacterial agents has become one of the highest priorities of modern medicine.

Bacteriophages are naturally occurring viruses that kill bacteria. Since their mechanism of action is completely different to that of antibiotics, they could be effective against bacteria that have become resistant to antibiotics. In addition, bacteriophages usually target only a single species or bacterial strain. Therefore, bacteriophages would ‘spare’ good bacteria, for example bacteria that do not cause illness, and limit the development of antimicrobial resistance.

Bacteriophages were used to treat bacterial infections in the 1920s and 1930s, but the therapy was abandoned in most European countries following the introduction of antibiotics. Doctors in some countries, mainly in Eastern Europe and the former Soviet Union, have continued to use bacteriophage therapy to treat certain types of infection such as wound infections. However, the efficacy and safety of bacteriophage therapy has not yet been studied systematically in large randomised controlled trials and most of the evidence remains observational.

In light of emerging antibiotic resistance, there has been renewed interest in this alternative treatment option. The therapeutic potential of bacteriophages is being investigated by research groups and pharmaceutical companies in the European Union, including in a phase I-II clinical trial in patients with infected burn wounds (the Phagoburn study), which is funded by the European Commission under the seventh Framework Programme for Research and DevelopmentExternal link icon.

With this workshop, EMA supports these efforts by providing a platform to proactively discuss current issues and open questions and reflect on potential ways forward for this therapy with various stakeholders.