The regulatory framework for microbiome-based therapies: insights into European regulatory developments.

IF 7.8 1区生物学 Q1 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

npj Biofilms and Microbiomes Pub Date : 2025-03-28 DOI:10.1038/s41522-025-00683-0

Julie Rodriguez, Magali Cordaillat-Simmons, Bruno Pot, Céline Druart

引用次数: 0

Abstract

The emergence of a broad spectrum of microbiome-based therapies has triggered changes in European regulatory frameworks. The first part of the review describes these innovative therapies. The second part provides an overview of the current framework and key changes introduced by the Regulation on substances of human origin (SoHO) for the development of microbiome-based therapies, highlighting the need of microbiome regulatory science to unlock the full potential of microbiome-based therapies.

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基于微生物组的疗法的监管框架：对欧洲监管发展的见解。

广泛的基于微生物组的治疗方法的出现引发了欧洲监管框架的变化。回顾的第一部分描述了这些创新疗法。第二部分概述了人类来源物质（SoHO）法规对基于微生物组的疗法发展的当前框架和关键变化，强调了微生物组调控科学的必要性，以释放基于微生物组的疗法的全部潜力。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

npj Biofilms and Microbiomes Immunology and Microbiology-Microbiology

CiteScore

12.10

自引率

3.30%

发文量

审稿时长

9 weeks

期刊介绍： npj Biofilms and Microbiomes is a comprehensive platform that promotes research on biofilms and microbiomes across various scientific disciplines. The journal facilitates cross-disciplinary discussions to enhance our understanding of the biology, ecology, and communal functions of biofilms, populations, and communities. It also focuses on applications in the medical, environmental, and engineering domains. The scope of the journal encompasses all aspects of the field, ranging from cell-cell communication and single cell interactions to the microbiomes of humans, animals, plants, and natural and built environments. The journal also welcomes research on the virome, phageome, mycome, and fungome. It publishes both applied science and theoretical work. As an open access and interdisciplinary journal, its primary goal is to publish significant scientific advancements in microbial biofilms and microbiomes. The journal enables discussions that span multiple disciplines and contributes to our understanding of the social behavior of microbial biofilm populations and communities, and their impact on life, human health, and the environment.