All products within the scope of the regulatory framework for biologicals 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
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