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Faecal microbiota transplantation : a regulatory hurdle?

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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.
Keywords
Regulatory affairs, Faecal microbiota transplantation, C. difficile Infection, Pseudomembranous colitis, CLOSTRIDIUM-DIFFICILE INFECTION, RANDOMIZED CLINICAL-TRIAL, HEALTH-CARE-SYSTEM, OPEN-LABEL, METAANALYSIS, DISEASE, BURDEN, VANCOMYCIN, THERAPY, FROZEN

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Citation

Please use this url to cite or link to this publication:

MLA
Verbeke, Frederick, Yorick Janssens, Evelien Wynendaele, et al. “Faecal Microbiota Transplantation : a Regulatory Hurdle?” BMC GASTROENTEROLOGY 2017 : n. pag. Print.
APA
Verbeke, Frederick, Janssens, Y., Wynendaele, E., & De Spiegeleer, B. (2017). Faecal microbiota transplantation : a regulatory hurdle? BMC GASTROENTEROLOGY.
Chicago author-date
Verbeke, Frederick, Yorick Janssens, Evelien Wynendaele, and Bart De Spiegeleer. 2017. “Faecal Microbiota Transplantation : a Regulatory Hurdle?” Bmc Gastroenterology.
Chicago author-date (all authors)
Verbeke, Frederick, Yorick Janssens, Evelien Wynendaele, and Bart De Spiegeleer. 2017. “Faecal Microbiota Transplantation : a Regulatory Hurdle?” Bmc Gastroenterology.
Vancouver
1.
Verbeke F, Janssens Y, Wynendaele E, De Spiegeleer B. Faecal microbiota transplantation : a regulatory hurdle? BMC GASTROENTEROLOGY. 2017.
IEEE
[1]
F. Verbeke, Y. Janssens, E. Wynendaele, and B. De Spiegeleer, “Faecal microbiota transplantation : a regulatory hurdle?,” BMC GASTROENTEROLOGY, vol. 17. 2017.
@misc{8558827,
  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.},
  articleno    = {128},
  author       = {Verbeke, Frederick and Janssens, Yorick and Wynendaele, Evelien and De Spiegeleer, Bart},
  issn         = {1471-230X},
  keywords     = {Regulatory affairs,Faecal microbiota transplantation,C. difficile Infection,Pseudomembranous colitis,CLOSTRIDIUM-DIFFICILE INFECTION,RANDOMIZED CLINICAL-TRIAL,HEALTH-CARE-SYSTEM,OPEN-LABEL,METAANALYSIS,DISEASE,BURDEN,VANCOMYCIN,THERAPY,FROZEN},
  language     = {eng},
  pages        = {11},
  series       = {BMC GASTROENTEROLOGY},
  title        = {Faecal microbiota transplantation : a regulatory hurdle?},
  url          = {http://dx.doi.org/10.1186/s12876-017-0687-5},
  volume       = {17},
  year         = {2017},
}

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