Faecal microbiota transplantation: a regulatory hurdle?

被引：24

作者：

Verbeke, Frederick ^{[1
]}

Janssens, Yorick ^{[1
]}

Wynendaele, Evelien ^{[1
]}

De Spiegeleer, Bart ^{[1
]}

机构：

[1] Univ Ghent, Drug Qual & Registrat DruQuaR Grp, Fac Pharmaceut Sci, Ottergemsesteenweg 460, B-9000 Ghent, Belgium

来源：

BMC GASTROENTEROLOGY | 2017年 / 17卷

关键词：

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;

D O I：

10.1186/s12876-017-0687-5

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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.

引用

页数：11

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