The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Biologicals were initially defined to be a thing made from, or that contains, human cells or human cells or human tissues in Part 3-2 A of the Act. This definition covers a subtype of xenotransplant products involving exposure of human body cells or tissues that have had contact with live animal tissues outside the patient's body. However, live animal cells, tissues and organs were still defined as Medicines.
As of April 2017, goods that comprise or contain live animal cells, tissues or organs are also regulated as biologicals.
The information below outlines some standards and guidance that apply to live animal cell, tissue or organ products, but this list is not comprehensive. If you are developing such a product for supply in to clinical trials or for broader supply following market authorisation, then please contact TGA at bloodandtissues@health.gov.au to discuss requirements that may apply.
Applicable standards
The following standards are applicable to the biologicals that comprise or contain live animal cells, tissues or organs:
- Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013 - external site to provide that the applicable manufacturing principles for therapeutic goods that are things that comprise or contain live animal cells, tissues or organs are those set out in Division 1 of the Manufacturing Principles, and not those set out in Division 2, which would otherwise apply to them, as biologicals.
- TGO 107 General requirements for labelling of biologicals - external site
In the absence of a therapeutic goods order, therapeutic goods, including 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 - external site, European Pharmacopoeia, and United States Pharmacopeia - National Formulary - external site which are mandated through the Therapeutic Goods Act 1989.
Recognising the differences between biologicals of human and animal origin the following Standards are only applicable for biologicals of human origin:
- Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013
- TGO 107 General requirements for labelling of biologicals - external site
- TGO 108 Standard for Human Cell and Tissue Products - Donor Screening Requirements - external site
- TGO 109 Standards for Biologicals - General and Specific Requirements - external site
Guidelines on quality, safety and efficacy aspects for live animal cells, tissues and organs
Internationally guidance on the safe development and use of xenotransplant products, especially in clinical trials, has been published by several bodies including the WHO, the EMEA and the US FDA (see below). These documents clearly outline safety considerations around infectious disease issues such as sourcing of animals, design of the manufacturing process and characterisation of the products and pre-clinical and clinical considerations.
The TGA has adopted the EMEA Guideline on Xenogeneic Cell-based Medicinal Products, 2010.
Other guidance documents that may be useful include:
- WHO - Xenotransplantation - external site
- EMEA Points to consider on xenogeneic cell therapy medicinal products - external site
- EMEA Guideline on xenogeneic cell-based medicinal products - external site
- FDA Xenotransplant guidelines - external site
- The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in Type I diabetes