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
In July 2011 updates to legislation for the regulation of biologicals became available via the TGA Legislation and legislative instruments page. This included therapeutic goods orders detailing product standards for:
- human musculoskeletal tissue
- human cardiovascular tissue
- human ocular tissue
- human skin
- general requirements for labelling of biologicals
Detailed guidance on the above standards is available in the Australian Regulatory Guidelines for Biologicals.
Therapeutic goods must be manufactured in accordance with the relevant manufacturing principles. The Therapeutic Goods (Manufacturing Principles) Determinations specify which manufacturing principles apply to which therapeutic goods.
Different manufacturing principles apply to different kinds of biologicals.
- Biologicals that comprise, contain or are derived from human cells and tissues, or are specified as a biological by the Secretary, must comply with the Australian code of GMP for human blood and blood components, human tissues and human cellular therapy products.
- Biologicals that comprise or contain live animal cells, tissues or organs must comply with the PIC/S guide to GMP, except for annexes 4, 5, 14 and 16 (the same manufacturing principles that apply to medicines).
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 provided by the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia - National Formularywhich are mandated through the Therapeutic Goods Act 1989.
Demonstrating compliance with standards
Sponsors must ensure that the product dossier that is submitted with their biological application includes information demonstrating compliance with all relevant standards, as outlined in the dossier requirements of the Australian Regulatory Guidelines for Biologicals.
The Australian Regulatory Guidelines for Biologicals provide sponsors, manufacturers, and the general public information on the regulation of biologicals. Information regarding compliance with default standards for medicines may also apply to some biologicals.
Information on manufacturing requirements for biologicals is available on the 'manufacturing biologicals' page.
If you have any queries or would like further information please contact the TGA.