The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for Clostridioides difficile Infection in Italy

Faecal microbiota transplantation (FMT) is regarded as an efficacious treatment for recurrent C. difficile infection. Unfortunately, widespread patient access is hindered by regulatory hurdles, which are the primary barriers to incorporating FMT into clinical practice. At the European and International level, there is no uniform perspective on FMT classification, and a coordinated effort is desirable to solve this regulatory puzzle. In this communication, we report the regulatory principles and the implementation approach for FMT application in Italy. Our experience suggests that the EU Tissue and Cell Directives are suited to ensure safe and efficient FMT for C. difficile management, especially through extensive high-quality donor selection and full traceability maintenance.

Automated summary

The classification of faecal microbiota transplantation (FMT) lacks a uniform perspective at the European and International level, hindering its widespread incorporation into clinical practice. In Italy, the EU Tissue and Cell Directives are implemented to ensure safe and efficient FMT for the management of recurrent C. difficile infection through rigorous donor selection and traceability maintenance.