Applicable standards for biologicals
The applicable standards for biologicals.
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:
- Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021.
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.
Different manufacturing principles apply to different kinds of biologicals. Refer to:
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:
Demonstrating compliance with standards
If you have any queries or would like further information please contact us.
Guidance and resources
- GuidanceStandards 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
- GuidanceThis guidance is for manufacturers, sponsors and providers of biologicals and human cell and tissue (HCT) materials.
- ARGB Appendix 12 - Guidance on TGO 108: Standard for Human Cell or Tissue Products - Donor Screening RequirementsGuidanceThis guidance is for manufacturers and sponsors of biologicals and human cell or tissue (HCT) products.
- 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