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BMC Gastroenterology
Published in: BMC Gastroenterology 1/2017

Open Access 01-12-2017 | Debate

Faecal microbiota transplantation: a regulatory hurdle?

Authors: Frederick Verbeke, Yorick Janssens, Evelien Wynendaele, Bart De Spiegeleer

Published in: BMC Gastroenterology | Issue 1/2017

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Abstract

During faecal microbiota transplantation, stool from a healthy donor is transplanted to treat a variety of dysbiosis-associated gut diseases. Competent authorities are faced with the challenge to provide adequate regulation. Currently, regulatory harmonization is completely lacking and authorities apply non-existing to most stringent requirements. A regulatory approach for faecal microbiota transplantation could be inserting faecal microbiota transplantation in the gene-, cell- and tissue regulations, including the hospital exemption system in the European Advanced Therapy Medicinal Products regulation, providing a pragmatic and efficacy-risk balanced approach and granting all patients as a matter of principle access to this therapy.
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Metadata
Title
Faecal microbiota transplantation: a regulatory hurdle?
Authors
Frederick Verbeke
Yorick Janssens
Evelien Wynendaele
Bart De Spiegeleer
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Gastroenterology / Issue 1/2017
Electronic ISSN: 1471-230X
DOI
https://doi.org/10.1186/s12876-017-0687-5

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