Home › Forums › Infexion Connexion › FW: TGA regulations for faecal microbiota transplant (FMT) products in Australia.
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Glenys Harrington.
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22/09/2019 at 12:01 pm #75828
Glenys Harrington
ParticipantAuthor:
Glenys HarringtonPosition:
ConsultantOrganisation:
Infection Control Consultancy (ICC)State:
Dear all,
Find below the newly released “TGA regulations for faecal microbiota
transplant (FMT) products in Australia”.“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”.Regards
Glenys
Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
P.O. Box 6385
Melbourne
Australia, 3004
M: +61 404816434
Dear Stakeholder
For your information, we’d like to share our recently published TGA
statement on the regulation of FMT products in Australia:https://www.tga.gov.au/tga-regulation-faecal-microbiota-transplant-fmt-produ
cts-australiaIf you have any further questions about the regulation of FMT products in
Australia, please contact us at this address: bloodandtissues@tga.gov.auKind regards
Biological Science Section
Scientific Evaluation Branch
Medicines Regulation Division | Health Products Regulation Group
Australian Government Department of Health
PO Box 100, Woden ACT 2606, Australia
The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We pay
our respects to all Elders past and present._____
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