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TGA regulation of faecal microbiota transplant (FMT) products in Australia

19 September 2019

Following the information and feedback from a stakeholder forum in October 2018 and a public consultation in early 2019, the Minister for Health has determined the model by which the collection, manufacture and supply of faecal microbiota transplant (FMT) products are to be regulated in Australia.

What are FMT products?

By definition, FMT products comprise, contain, or are derived from donated human stool and are introduced into a recipient person for a therapeutic use. Human stool is collected from a screened donor by defaecation. This stool is then processed into an FMT product and provided to the recipient via enema, colonoscopy, nasoenteric tube, or orally (e.g. capsules). Where FMT products meet the definition of a therapeutic good, they will be regulated by TGA under the Therapeutic Goods Act 1989, for example, if they are used in the treatment or prevention of a disease, ailment, defect or injury affecting humans. Currently, FMT products have sound clinical evidence of efficacy for the treatment of recurrent Clostridium difficile infection (CDI), an often serious bacterial infection of the gut, and emerging evidence of efficacy for treatment of ulcerative colitis (UC), a chronic relapsing-remitting mucosal inflammatory bowel disease (IBD). There is also increasing interest in the use of FMT products for a range of other conditions.

What is the regulatory model for FMT products?

From the four regulatory options for FMT products outlined in the consultation paper, the preferred regulatory model is for TGA to regulate most FMT products as 'biologicals' under the current TGA Biologicals Framework. In instances of more purified and commercially cultured FMT products, better known as 'defined microbial therapeutics', these will instead be regulated as 'medicines'. The level of regulation for any given FMT product will depend on the level of processing and supply of the FMT product, and the level of clinical oversight.

Under the new regulatory model, FMT products will be classified as either:

  • Class 1 biologicals, in the case of minimally manipulated FMT products from appropriately screened donors which are manufactured in a hospital and used in that hospital under the supervision of a registered medical practitioner who has clinical care of the recipient patient. Sponsors of Class 1 biologicals will need to comply to applicable standards and have an appropriate quality management system in place. The sponsor will need to submit an application for the FMT product to be included in the Australian Register of Therapeutic Goods (ARTG). However, the manufacturer does not need to hold a Good Manufacturing Practice (GMP) licence, and does not require pre-market assessment of supporting data by TGA.
  • Class 2 biologicals, in the case of minimally manipulated FMT products from appropriately screened donors which are manufactured in a facility that is not a hospital or manufactured and used in different hospitals or clinics. For Class 2 biologicals, these are required to be included in the ARTG and have GMP licensing for all manufacturing and testing facilities.
  • Class 3 or 4 biologicals or medicines, in the case of FMT products from appropriately screened donors which have been processed using methods that may have altered any of the biological characteristics or physiological functions of the stool. For Class 3 or 4 biologicals or medicines, these are required to be included in the ARTG and have GMP licensing for all manufacturing and testing facilities.

Why has this regulatory model been adopted for FMT products?

The new regulatory model seeks to strike a balance between ensuring appropriate safety levels for the Australian public and maintaining patient access to FMT products. The new model also recognises the current high level of clinical oversight and hospital governance for some FMT products, which has led to the designation of these products as Class 1 biologicals. Supply of FMT products outside of a hospital (i.e. not Class 1 biologicals) is equivalent to the supply of other biologicals such as tissues, and as such, the same level of regulation applies (i.e. as Class 2-4 biologicals).

In this way, the new regulatory landscape for FMT products is not expected to undermine current practice, allowing ongoing patient access, while at the same time setting standards for continued product development.

When do the new regulatory provisions for FMT products commence?

It is acknowledged that these new regulatory requirements should be introduced with a reasonable transition period to allow time for current providers of FMT products to understand how the changes will impact them, to allow them time to comply, and to ensure ongoing access for patients. 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.

What is next?

During the remainder of 2019, TGA will work to amend relevant legislation, and develop more detailed guidance for the sector on the proposed regulation. TGA will also work to develop an appropriate FMT product Standard that will specify the minimal requirements for donor and product screening, and provide specific guidance on manufacturing requirements. In designing the Standard, TGA will collaborate with providers of FMT products and specialist working groups, and refer to international standards. Prior to adoption, the Standard will be presented to the sector for consultation. TGA will also develop guidance addressing what GMP licensing of an FMT facility for Class 2 biologicals will entail, and what will be required for a dossier to be evaluated by TGA.

Where can I source more information?

Extensive guidance on the current Biologicals Framework has been published on the TGA website.

Further questions about the regulation of FMT products in Australia can be directed to current providers of FMT products or to TGA via email: bloodandtissues@tga.gov.au.