Table 1.

Examples of different approaches to FMT regulation

Regulatory classification	Characteristics	Example jurisdictions
Biological agent	Stringent regulation, restricted use. Recognised as complex mixtures that are not easily identified or characterised, but should be standardised. Often derived/isolated from living organisms. Sensitive to external environmental factors (e.g. temperature, exposure to light)	USA (investigational), Canada (investigational), Australia
Human cell/tissue product	Tiered regulation according to risk: low risk tier covers tissues and cells that are not ‘substantially manipulated’ e.g. traditional transplants, higher risk tier covers products and therapies subject to additional processes and manipulation.	Netherlands, Belgium, Italy
Medicinal product (non-biologic)	Variable regulation according to jurisdiction. Product is well characterised and should have well defined structure/mechanism of action. Pharmacokinetic and dose-ranging studies inform appropriate dosage.	UK, Ireland, France, Germany, Switzerland
Medical procedure/unregulated	Considered normal practice of medicine. Decisions regarding donor screening and processing are delegated to clinicians/institutions. Regulatory oversight is devolved or involves self-regulation with voluntary reporting of adverse events.	Austria, Denmark, Sweden, Finland