中国临床药理学杂志2025，Vol.41Issue(3)：445-450,6.DOI:10.13699/j.cnki.1001-6821.2025.03.030
不同国家粪菌产品的监管策略研究及思考
Research and consideration on regulatory strategies for fecal microbiota products in different countries
尹华静 1陈一飞 2尹茂山 1孙涛1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100076
- 2. 上海药品审评核查中心创新与监管科学发展部,上海 201210||华东师范大学-上海药品审评核查中心药品监管科学联合研究中心,上海 201210
- 折叠
摘要
Abstract
In recent years,fecal microbiota for transplantation(FMT)has developed rapidly as a potential intervention for numerous conditions that may be caused by gut microbiota disorders and there are fecal microbiota products(FMP)have been approved to treat recurrent Clostridioides difficile infection(rCDI).There is currently no unified positioning and regulatory measures for FMP internationally,which poses challenges for the development of such products.This article proposes several thoughts on the regulation and evaluation of FMP based on reviewing the regulatory strategies of different countries for FMP and the research and regulatory situation of approved products,in order to provide reference for the development and application of such products.关键词
粪菌移植/药品监管/活生物制剂Key words
fecal microbiota for transplantation/drug administration/live biotherapeutic product分类
医药卫生引用本文复制引用
尹华静,陈一飞,尹茂山,孙涛..不同国家粪菌产品的监管策略研究及思考[J].中国临床药理学杂志,2025,41(3):445-450,6.
