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ARGB Appendix 10: Guidance on TGO 105: Standards for faecal microbiota transplant (FMT) products
Australian Regulatory Guidelines for Biologicals (ARGB)
14 September 2020
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Description
This guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in the Therapeutic Goods (Standards for Faecal Microbiota Transplant Products) (TGO 105) Order 2020 as prepared by the Therapeutic Goods Administration (TGA).
Contents
- About this guidance
- General information about TGO 105
- Guidance on the requirements of TGO 105
Version history
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | Biological Science Section, Scientific Evaluation Branch | September 2020 |
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