Optimizing the European regulatory framework for sustainable bacteriophage therapy in human medicine

Arch Immunol Ther Exp (Warsz). 2012 Jun;60(3):161-72. doi: 10.1007/s00005-012-0175-0. Epub 2012 Apr 17.


For practitioners at hospitals seeking to use natural (not genetically modified, as appearing in nature) bacteriophages for treatment of antibiotic-resistant bacterial infections (bacteriophage therapy), Europe's current regulatory framework for medicinal products hinders more than it facilitates. Although many experts consider bacteriophage therapy to be a promising complementary (or alternative) treatment to antibiotic therapy, no bacteriophage-specific framework for documentation exists to date. Decades worth of historical clinical data on bacteriophage therapy (from Eastern Europe, particularly Poland, and the former Soviet republics, particularly Georgia and Russia, as well as from today's 27 EU member states and the US) have not been taken into account by European regulators because these data have not been validated under current Western regulatory standards. Consequently, applicants carrying out standard clinical trials on bacteriophages in Europe are obliged to initiate clinical work from scratch. This paper argues for a reduced documentation threshold for Phase 1 clinical trials of bacteriophages and maintains that bacteriophages should not be categorized as classical medicinal products for at least two reasons: (1) such a categorization is scientifically inappropriate for this specific therapy and (2) such a categorization limits the marketing authorization process to industry, the only stakeholder with sufficient financial resources to prepare a complete dossier for the competent authorities. This paper reflects on the current regulatory framework for medicines in Europe and assesses possible regulatory pathways for the (re-)introduction of bacteriophage therapy in a way that maintains its effectiveness and safety as well as its inherent characteristics of sustainability and in situ self-amplification and limitation.

Publication types

  • Review

MeSH terms

  • Anti-Bacterial Agents / therapeutic use
  • Bacterial Infections / therapy*
  • Bacteriophages*
  • Clinical Trials, Phase I as Topic*
  • Complementary Therapies* / classification
  • Complementary Therapies* / legislation & jurisprudence
  • Complementary Therapies* / standards
  • Cooperative Behavior
  • Drug Resistance, Bacterial*
  • Europe
  • European Union
  • Government Regulation
  • Guidelines as Topic*
  • Humans
  • Interinstitutional Relations
  • Marketing / legislation & jurisprudence


  • Anti-Bacterial Agents