Faecal microbiota transplantation: a regulatory hurdle?

Area of Science:

• Gastroenterology
• Microbiology
• Regulatory Science

Background:

• Faecal microbiota transplantation (FMT) is a therapy for dysbiosis-associated gut diseases.
• Regulatory frameworks for FMT are currently inadequate and lack harmonization globally.
• Competent authorities face challenges in establishing consistent and appropriate regulations for FMT.

Purpose of the Study:

• To propose a regulatory strategy for faecal microbiota transplantation.
• To address the lack of regulatory harmonization for FMT.
• To ensure patient access to FMT while balancing efficacy and risk.

Main Methods:

• Review of current regulatory landscapes for FMT.
• Analysis of existing European regulations for Advanced Therapy Medicinal Products (ATMPs).
• Proposal for integrating FMT into gene, cell, and tissue regulations, including the hospital exemption system.

Main Results:

• Significant lack of regulatory harmonization for FMT exists.
• Current regulatory requirements vary widely among authorities.
• A proposed regulatory approach could provide a pragmatic solution.

Conclusions:

• Integrating FMT into gene, cell, and tissue regulations, specifically within the ATMPs hospital exemption system, is a viable regulatory approach.
• This approach offers a pragmatic balance between efficacy and risk.
• It can grant patients broader access to FMT as a standard therapy.