New guidance on faecal microbiota transplant (FMT) products has been released by the TGA. The two documents include a FMT product Standard that specifies the minimal requirements for donor and product screening; and specific guidance on manufacturing requirements.
The guidance has been released following regulatory changes in late 2019. The new model seeks to strike a balance between ensuring appropriate safety levels for the Australian public and maintaining patient access to the products.
FMT products are used to repopulate the bacterial micro-environment in a recipient's bowel with healthy microorganisms. All FMT products are regulated as biologicals.
Guidance on TGO 105: Standards for faecal microbiota transplant (FMT) products
Therapeutics Goods Order (TGO) 105 specifies the minimum criteria donor and product screening to minimise the risk of infectious transmission during the manufacture of FMT products. The guidance has a commencement date of 1 July 2021, enabling a transition period for sponsors to meet the requirements.
Read the guidance on TGA 105 here.
Interpretative and technical guidance on GMP requirements
This guidance is for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products and provides information on TGA manufacturing license requirements; and TGA interpretation and expectations for compliance. It includes specific sections of the GMP for human blood and blood components, human tissues and human cellular therapy products.
Read the guidance on GMP requirements here.