Australia – TGA Adopts Risk-Based Model for Fecal Microbiota Transplants

Australia’s Therapeutic Goods Administration (TGA) has adopted a risk-based approach to the regulation of fecal microbiota transplants (FMT). TGA decided to treat FMT products as anything from Class 1 biologicals to Class 4 medicines after running a public consultation earlier in the year.

The model TGA settled on will result in most FMT products being categorized as Class 1 biologicals, the term the agency uses to describe tissue and cell-based products. TGA will treat FMT products as Class 1 biologicals if they are minimally manipulated, use feces from “appropriately screened donors” as the starting point and are manufactured and used in the same hospital under the supervision of the registered medical practitioner who is caring for the patient who will receive the transplant.

TGA will place some regulatory responsibilities on sites that handle Class 1 biologicals. The agency expects the sites to comply with certain standards and have “an appropriate” quality management system. The site will need to file for the FMT product to be added to the Australian Register of Therapeutic Goods (ARTG) but will be spared the need to hold a good manufacturing practice (GMP) license or undergo premarket assessment by TGA…