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All products within the scope of the regulatory framework for biologicals must comply with the legislative requirements.
Standards for infectious disease minimisation
Unless exempt, sponsors and manufacturers of blood, blood components, haematopoietic progenitor cells (HPCs) and biologicals, must meet the requirements of:
- Therapeutic Goods Order No. 88 - Standards 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.
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:
- human musculoskeletal tissue (TGO 83)
- human cardiovascular tissue (TGO 84)
- human ocular tissue (TGO 85)
- human skin (TGO 86)
- general requirements for labelling of biologicals (TGO 87)
- faecal microbiota transplant (FMT) products (TGO 105)
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
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