Regulation of faecal microbiota transplant

Faecal microbiota transplantation (FMT) is recognised as an emerging treatment for recurrent Clostridium difficile infections in patients where antibiotic and other lines of treatment have failed.

FMT is outside the scope of the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) and is not regulated by the HTA.

Establishments seeking to perform FMT should contact the MHRA Medicines Borderline Section for further advice.