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Research and consideration on regulatory strategies for fecal microbiota products in different countries
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Hua-jing YIN1, Yi-fei CHEN2, 3, Mao-shan YIN1, Tao SUN1
Chinese Journal of Clinical Pharmacology | 2025, 41(3) : 445 - 450
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Chinese Journal of Clinical Pharmacology | 2025, 41(3): 445-450
• Drug Evaluation and Administration •
Research and consideration on regulatory strategies for fecal microbiota products in different countries
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Hua-jing YIN1, Yi-fei CHEN2, 3, Mao-shan YIN1, Tao SUN1
Affiliations
  • 1.Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
  • 2.Innovation and Regulatory Science Development Department, Shanghai Center for Drug Evaluation and Inspection, Shanghai 201210, China
  • 3.ECNU-SCDEI Collaborative Research Center for Drug Regulatory Science, Shanghai 201210, China
Published: 2025-02-17 doi: 10.13699/j.cnki.1001-6821.2025.03.030
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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.

fecal microbiota for transplantation  /  drug administration  /  live biotherapeutic product
Hua-jing YIN, Yi-fei CHEN, Mao-shan YIN, Tao SUN. Research and consideration on regulatory strategies for fecal microbiota products in different countries[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (3) : 445 -450 . DOI: 10.13699/j.cnki.1001-6821.2025.03.030
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Article Info
doi: 10.13699/j.cnki.1001-6821.2025.03.030
  • Receive Date：2024-08-20
  • Online Date：2026-08-04
  • Published：2025-02-17
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  • Received：2024-08-20
Affiliations
    1.Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
    2.Innovation and Regulatory Science Development Department, Shanghai Center for Drug Evaluation and Inspection, Shanghai 201210, China
    3.ECNU-SCDEI Collaborative Research Center for Drug Regulatory Science, Shanghai 201210, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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