New regulatory framework for faecal microbiota transplant (FMT) in Australia

Following a broad consultation, 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.

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.

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.

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.

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