After a borad consultation, the TGA has issued a notice outlining how the collection, manufacture and supply of faecal microbiota transplant (FMT) products are to be regulated in Australia.
The new regulatory model will see the TGA 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 its level of processing and supply, and the level of clinical oversight.
The new model seeks to strike a balance between ensuring appropriate safety levels for the Australian public and maintaining patient access to the products. The 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.
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, therefore commencing from 1 January 2021.
The TGA will work to amend relevant legislation and develop more detailed guidance for the sector on the proposed regulation. It will also 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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