TGA Australian Guidance

2014. Therapeutic Goods Administration. Australian Regulatory Guidelines for Biologicals: Appendix 4 Guidance on TGO 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. Australia.

2013. Therapeutic Goods Administration. 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. Australia.

2013. Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013. Australia.

2011. Therapeutic Goods Administration. Australian Regulatory Guidelines for Biologicals Part 1 – Introduction to the Australian Regulatory Guidelines for Biologicals. Australia.

2011. Therapeutic Goods Administration. Australian Regulatory Guidelines for Biologicals Part 2 – Regulatory lifecycle for biologicals that are included on the Australian Register for Therapeutic Goods. Australia.

2011. Therapeutic Goods Administration. Australian Regulatory Guidelines for Biologicals Part 3 – Access to unapproved biologicals. Australia.

2008.  Therapeutic Goods Administration. Guideline for the Preparation of Technical Master Files for Blood, Blood Components and Haematopoietic Progenitor Cells Third edition. Australia.