All biologicals regulated as therapeutic goods must comply with the legislative requirements.
Standards for donor selection
Unless exempt, sponsors and manufacturers of blood, blood components, haematopoietic progenitor cells (HPCs) and biologicals, must meet the requirements of:
Product specific standards (TGOs)
Product specific standards refer to Therapeutic Goods Orders (TGOs) that specify the legal requirements for the different product types, including labelling:
- faecal microbiota transplant (FMT) products (TGO 105)(link is external)
- Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021(link is external)
- Therapeutic Goods (Standards for Biologicals—General and Specific Requirements) (TGO 109) Order 2021(link is external)
Detailed guidance on the above standards is available in the Australian Regulatory Guidelines for Biologicals.
Manufacturing principles
Different manufacturing principles apply to different kinds of biologicals. Refer to:
Default standards
In the absence of a therapeutic goods order biologicals, must comply with any default standards that are relevant to the product being supplied. Default standards are publicly available authoritative standards which are mandated through the Therapeutic Goods Act 1989 and provided by the:
- British Pharmacopoeia
- European Pharmacopoeia
- United States Pharmacopeia - National Formulary
Demonstrating compliance with standards
If you have any queries or would like further information please contact us.
Guidance and resources
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Reference materialThis guidance is no longer in use and has been replaced by ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific Requirements.
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Reference materialThis guidance is no longer in use and has been replaced by ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific Requirements.
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Reference materialThis guidance is no longer in use and has been replaced by ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific Requirements.
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Reference materialStandards for human skin. This guidance is no longer in use and has been replaced by ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific Requirements.
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Reference materialLabelling Order. This guidance is no longer in use and has been replaced by ARGB Appendix 11 - Guidance on TGO 107: Standard for Biologicals – Labelling Requirements.
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Reference materialStandards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products
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GuidanceThis guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in TGO 105.
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GuidanceMandatory labelling requirements for biologicals and human cell and tissue materials.
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GuidanceRequirements around the minimisation of transmission of communicable diseases for therapeutic goods containing biologicals and human cell or tissue (HCT).
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GuidanceGuidance on TGO 109: Standards for Biologicals - General and Specific Requirements.
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Reference materialThe standards have been remade and revised guidance published.
More information
- Biological standards
- Guidance on biological standards
- Post-market responsibilities (biologicals)
- Exceptional release of biologicals (post-market)
- Clause-by-Clause tracking - TGO107 - New to Old
- Clause-by-Clause tracking - TGO108 - New to Old
- Clause-by-Clause tracking for TGO109 from sunsetting standards