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©The Author(s) 2026.
World J Methodol. Mar 20, 2026; 16(1): 108875
Published online Mar 20, 2026. doi: 10.5662/wjm.v16.i1.108875
Table 7 Regulatory variations in fecal microbiota transplantation
Country
FMT classification
United StatesRestricted use in CDI in line with FDA enforcement discretion policy[78]; investigational new drug approval used in context of clinical trials for other diseases
Belgium, Netherlands, ItalyRegulated as a tissue transplant, under European Union Tissue and Cells Directive
AustraliaRegulated as a biological drug
United Kingdom, Germany, France, Ireland, SwitzerlandRegulated as a medicinal drug -flexible use allowed


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