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Biological standards

24 November 2021

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:

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:

Demonstrating compliance with standards

If you have any queries or would like further information please contact us.