Donated stool for faecal microbiota transplantation is not a drug, but guidance and regulation are needed

We would like to thank Mikkelsen et al. for their response to our statement that stool for faecal microbiota transplantation (FMT) should be classified as transplantation product. Fortunately, we all agree that guidance and regulation is required for this rapidly emerging treatment, which makes the use of donated stool a substance of human origin (SoHO). The European Union Tissue and Cell Directives (EUTCD) cover the processing, preservation,...