There are currently no authorised clinical trials in Ireland using faecal microbial transplantation (FMT), a spokesperson for the Health Products Regulatory Authority (HPRA) has told this newspaper.
FMT involves the transfer of stool from a healthy donor into the gastrointestinal tract for the purpose of treating recurrent Clostridium difficile infection (CDI).
Last year there were 2,053 notifications of CDI, up from 1,763 in 2017, according to provisional figures released by the Health Protection Surveillance Centre.
In January 2017 the Medical Independent (MI) first reported that the HPRA was considering the regulation of FMT and planned to issue guidance.
In late 2018, the HPRA decided to classify FMT as a medicinal product and said it would accept applications for clinical trials using FMT as an investigational medicinal product. However, no products have received authorisation as yet.
“Following the decision to classify FMT as a medicinal product, the HPRA will accept applications for clinical trials using FMT as an investigational medicinal product,” a spokesperson for the HPRA told MI.
“There are no FMT products with a marketing authorisation at present and there are currently no authorised clinical trials approved in Ireland using FMT.
“In the absence of an authorised product and outside of an approved clinical trial, FMT can be supplied to specialist clinicians as an exempt medicinal product for use by their individual patients under their direct responsibility.”
In 2016, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) classified FMT as a medicinal product, not tissue, thus regulation of FMT changed from the UK Human Tissue Authority to the MHRA.
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