You can use your existing Medical Independent, MediLearning or PharmacistCPD account to log in.


Medicalindependent.ie is Ireland's only investigative medical news website for doctors, healthcare professionals and anyone with an interest in health issues.

Established in 2010, along with its sister publication The Medical Independent, our stated aim is to investigate and analyse the major issues affecting healthcare and the medical profession in Ireland. The Medical Independent has won a number of awards for its investigative journalism, and its stories are frequently picked up by national digital, broadcast and print media. The Medical Independent is published by GreenCross Publishing.

Address: Top Floor, 111 Rathmines Road Lr, Dublin 6

Tel: 353 (01) 441 0024

GreenCross Publishing is owned by Graham Cooke.


The benefits of registering: only registered users:
  • receive the ecCopy two days prior to the printed edition.
  • have automatic access to our free CPD sites.
  • can partake in our online MCQs.
  • can enter our online sports quiz.

Sign up now for ease of access to The Medical Independent, Ireland’s most frequently published medical newspaper, delivering award-winning news and investigative reporting.

Download the new Mindo app for both IOS & Android.

  • Get notified when a story goes live
  • Access Premium Content
  • Read Offline
 
[the_ad_placement id="main-ldb-public"]
[the_ad_placement id="main-ldb-mobile-public"]

You are reading 1 of 2 free-access articles allowed for 30 days

No clinical trials approved for FMT in Ireland

By Dermot - 29th Aug 2019 | 5 views

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.

Leave a Reply

[the_ad_placement id="main-ldb-public-2"]
[the_ad_placement id="main-ldb-mobile-public-2"]
Latest Issue
The Medical Independent – 24 June 2021

You need to be logged in to access this content. Please login or sign up using the links below.

[the_ad_placement id="main-mpu-public"]
Most Read
[the_ad_placement id="main-ldb-public-2"]
[the_ad_placement id="main-ldb-mobile-public-2"]