Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Bacteriophage therapy: an analysis of the European regulatory framework and its proposals for amendment ***

Carlos Canete (Abschlußjahr: 2018)

Summary
Language: English
After many decades of scarce use in EU countries, phage therapy is having a revival due to the emergence of MDR bacteria and the need for alternative treatments. More data are urgently needed to provide evidence that phage therapy is a credible therapeutic alternative orcomplement to chemical antibiotics against bacterial infections. The existing regulations for biological medicinal products in the EU, which were not conceived considering the unique characteristics of phage therapy, do not provide an optimal regulatory framework that would promote the development of this therapy and all the potential advantages that might offer against bacterial infections. At the moment, phage therapy is being used in Europe only in a named-patient basis under national provisions out of the scope of Directive 2001/83/EC. Several proposals have already been made in order to amend the existing European regulatory framework, mainly considering two approaches: a ready-to-use bacteriophage product, and a customised approach. This master thesis analyses the different proposals and their applicability for establishing specific regulatory provisions for phage therapy. The ready-to-use approach has bigger chances to bring some bacteriophage product in the market in coming years and would benefit from some minor changes in regulations, especially considering variations. The customised approach would require further amendments and is less likely to have a specific regulatory framework at EU level in a short term, but it should benefit from the developments of the ready-to-use approach and specific national strategies that will generate necessary data for the benefit-risk assessment of this model.
Pages: 57