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Biological standards
26 May 2021
All products within the scope of the regulatory framework for biologicals must comply with the legislative requirements.
Standards for infectious disease minimisation
The public consultation for remaking of this standard closes on Sunday 11 July 2021. Refer consultation hub
Unless exempt, sponsors and manufacturers of blood, blood components, haematopoietic progenitor cells (HPCs) and biologicals, must meet the requirements of:
Product specific standards (TGOs)
The public consultation for remaking of TGO83-87 closes on Sunday 11 July 2021. Refer consultation hub
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.
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.