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Faecal microbiota transplantation: a regulatory hurdle?

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Published:28th Nov 2018
Author: Verbeke F, Janssens Y, Wynendaele E, De Spiegeleer B.
Availability: Free full text
Ref.:BMC Gastroenterol. 2017;17(1):128.

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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