Australia Global regulatory parnters.


In a recent event following a public consultation TGA released new guidelines on fecal microbiota transplant (FMT) products which states that FMT products would either be Class 1 or 2 biologicals which well defines that such products either contains or are derived from human stools and introduced for various therapeutic aids.

FMT Product Classifications:

These categories of products would be made either by capturing fresh or frozen human stool through a rectal enema and are encapsulated for oral ingestion.

The TGA classifies the product categories based on their intended use and manufacturing, for example if it is manufactured at the hospital where the patient is treated it would fall under class 1 biologicals, whereas if it is made off site then it fits to Class 2 biologicals.

FMT Product Definitions:

By definition, FMT products “comprise, contain, or are derived from donated human stool and are introduced into a recipient person for a therapeutic use.

Currently, the guidelines are broadly defined and doesn’t consider the high-risk groups but states that it will all fall in the similar categories as per the classification of biologicals.

When do the new regulatory provisions for FMT products start?

It is anticipated that the new regulatory amendments for FMT products will be implemented on 1 January 2020 with a transition period of 12 months, i.e. commencement from 1 January 2021.


Therapeutic Goods Administration. Biologics Framework.

Share This Post: