Towards an EU-wide suitable regulatory framework for faecally derived industrially manufactured medicinal products

摘要

We read with great interest the editorial by Keller et al., reporting the need for guidance and legislation at national and European levels for human stool/faeces used for faecal microbiota transplantation (FMT). The authors of this editorial state they strongly believe that stool should be considered a transplant product, or be regarded equivalent in status to blood products used for transplantation or transfusion purposes’. We agree that a careful, multidisciplinary and proactive approach to the regulation of this emerging field would help prevent potentially avoidable adverse events and assure consistent efficacy.