• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

Towards an EU-wide suitable regulatory framework for faecally derived, industrially manufactured medicinal products.

作者信息

Mikkelsen Tue Anker, McIlroy James Roger, Mimiague Madeleine, Rouanet Alice, Sterkman Luc

机构信息

Ferring Pharmaceuticals, International PharmaScience Center, Copenhagen, Denmark.

EnteroBiotix, Aberdeen, United Kingdom.

出版信息

United European Gastroenterol J. 2020 Apr;8(3):351-352. doi: 10.1177/2050640620910313. Epub 2020 Feb 23.

DOI:10.1177/2050640620910313
PMID:32213033
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7184666/
Abstract
摘要

相似文献

1
Towards an EU-wide suitable regulatory framework for faecally derived, industrially manufactured medicinal products.建立一个适用于整个欧盟的粪便来源工业生产药品的监管框架。
United European Gastroenterol J. 2020 Apr;8(3):351-352. doi: 10.1177/2050640620910313. Epub 2020 Feb 23.
2
The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.欧盟关于（传统）草药产品质量的法律框架。
J Ethnopharmacol. 2014 Dec 2;158 Pt B:449-53. doi: 10.1016/j.jep.2014.07.044. Epub 2014 Jul 31.
3
[The use of nanotechnology in medicinal products in the light of European Union law].[从欧盟法律角度看纳米技术在医药产品中的应用]
Pol Merkur Lekarski. 2014 Dec;37(222):369-72.
4
Non-European traditional herbal medicines in Europe: a community herbal monograph perspective.欧洲的非欧洲传统草药：从社区草药专论角度看
J Ethnopharmacol. 2014 Oct 28;156:107-14. doi: 10.1016/j.jep.2014.08.021. Epub 2014 Aug 27.
5
The legal landscape for advanced therapies: material and institutional implementation of European Union rules in France and the United Kingdom.先进疗法的法律格局：欧盟规则在法国和英国的具体实施与制度情况
J Law Soc. 2012;39(1):131-49. doi: 10.1111/j.1467-6478.2012.00574.x.
6
Regulations applicable to plant food supplements and related products in the European Union.在欧盟适用的植物性食品补充剂和相关产品法规。
Food Funct. 2011 Dec;2(12):710-9. doi: 10.1039/c1fo10105f. Epub 2011 Oct 14.
7
From medical tradition to traditional medicine: A Tibetan formula in the European framework.从医学传统到传统医学：欧洲框架下的一个藏药配方
J Ethnopharmacol. 2015 Jun 5;167:108-14. doi: 10.1016/j.jep.2014.10.033. Epub 2014 Oct 29.
8
The regulatory framework of biosimilars in the European Union.欧盟生物类似药的监管框架。
Drug Discov Today. 2012 Jan;17(1-2):63-70. doi: 10.1016/j.drudis.2011.08.001. Epub 2011 Aug 12.
9
Regulatory structures for gene therapy medicinal products in the European Union.欧盟基因治疗医药产品的监管架构。
Methods Enzymol. 2012;507:337-54. doi: 10.1016/B978-0-12-386509-0.00017-X.
10
Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.加强和合理化欧盟的药物警戒：欧洲将走向何方？对新的欧盟药物警戒立法的审查。
Drug Saf. 2011 Mar 1;34(3):187-97. doi: 10.2165/11586620-000000000-00000.

引用本文的文献

1
The ladder of regulatory stringency and balance: an application to the US FDA's regulation of bacterial live therapeutics.监管严格性与平衡性的阶梯：应用于美国食品药品监督管理局对细菌活菌疗法的监管
Gut Microbes. 2025 Dec;17(1):2517377. doi: 10.1080/19490976.2025.2517377. Epub 2025 Jun 12.
2
Fecal microbiota transplantation: a tale of two regulatory pathways.粪便微生物群移植：两条监管途径的故事
Gut Microbes. 2025 Dec;17(1):2493901. doi: 10.1080/19490976.2025.2493901. Epub 2025 Apr 29.
3
The regulatory framework for microbiome-based therapies: insights into European regulatory developments.基于微生物组的疗法的监管框架：欧洲监管发展洞察
NPJ Biofilms Microbiomes. 2025 Mar 28;11(1):53. doi: 10.1038/s41522-025-00683-0.
4
Plumping up a Cushion of Human Biowaste in Regenerative Medicine: Novel Insights into a State-of-the-Art Reserve Arsenal.在再生医学中填充人体生物废物的“软垫”：一种最先进储备武器的新见解。
Stem Cell Rev Rep. 2022 Dec;18(8):2709-2739. doi: 10.1007/s12015-022-10383-3. Epub 2022 May 3.
5
The Regulatory Approach for Faecal Microbiota Transplantation as Treatment for Infection in Italy.意大利将粪便微生物群移植作为感染治疗方法的监管方法。
Antibiotics (Basel). 2022 Apr 5;11(4):480. doi: 10.3390/antibiotics11040480.

本文引用的文献

1
Stool for fecal microbiota transplantation should be classified as a transplant product and not as a drug.用于粪便微生物群移植的粪便应归类为移植产品，而非药物。
United European Gastroenterol J. 2019 Dec;7(10):1408-1410. doi: 10.1177/2050640619887579. Epub 2019 Nov 14.
2
How to: Establish and run a stool bank.如何建立和运行粪便库。
Clin Microbiol Infect. 2017 Dec;23(12):924-930. doi: 10.1016/j.cmi.2017.05.015. Epub 2017 May 19.