Faecal microbiota transplantation: a regulatory hurdle?

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 a...

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Bibliographic Details
Published in:BMC gastroenterology 2017-11, Vol.17 (1), p.128-128, Article 128
Main Authors: Verbeke, Frederick, Janssens, Yorick, Wynendaele, Evelien, De Spiegeleer, Bart
Format: Article
Language:English
Subjects:
C. difficile Infection
Debate
Faecal microbiota transplantation
Health aspects
Laws, regulations and rules
Microbiota (Symbiotic organisms)
Pseudomembranous colitis
Regulatory affairs
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Summary: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.
ISSN:1471-230X
1471-230X
DOI:10.1186/s12876-017-0687-5