After a lengthy consultation process, the TGA has opted for ‘light touch’ regulation of faecal microbiota transplant (FMT) products if they are manufactured and used in a hospital.
Under a new regulatory model that will come into effect from 1 January 2020, the TGA will waive TGA data assessment and Good Manufacturing Practice (GMP) requirements for FMT products used in hospital setting.
However FMT products that are made and used outside hospitals will have to be registered on the Australian Register of Therapeutic Goods (ARTG) and be subject to GMP standards.
FMT products will be classified as:
- Class 1 biologicals: minimally manipulated FMT products from appropriately screened donors, 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. Hospitals will need to comply to applicable standards and have an appropriate quality management system in place. They 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: 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. 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: FMT products from appropriately screened donors that have been processed using methods that may have altered any of the biological characteristics or physiological functions of the stool. Required to be included in the ARTG and have GMP licensing for all manufacturing and testing facilities.
The TGA says the model it has selected strikes the right balance between protecting public safety and ensuring easy access to FMT.
“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).”
A one year transition period will allow FMT centres time to comply with the new regulations before 1 January 2021.