Australian regulatory guidelines for biologicals (ARGB)

6 July 2017

The Australian Regulatory Guidelines for Biologicals (ARGB) provide information for manufacturers, sponsors, health professionals and the general public on the legal arrangements in Australia for the supply of goods derived from human cell and tissues, and living animal cells, tissues and organs (collectively defined as 'biologicals').

This guide:

  • Explains which products are included in the new Biologicals Regulatory Framework, and why.
  • Describes transition arrangements that apply for up to three years to allow all biologicals to meet the new arrangements.
  • Explains the Australian regulatory requirements for supplying biological.
  • Sets out what is required for making an application to the TGA for biologicals, so they can be processed as quickly as possible.
  • Allows sponsors, manufacturers, health professionals, regulators and consumers, to openly access information on biologicals, the Therapeutic Goods Act, and related matters.

If you have any queries or comments to make on the ARGB please contact the Biological Sciences Section of the TGA:

ARGB

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ARGB parts

Part 1 - Introduction to the Australian Regulatory Guidelines for Biologicals

Part 2 - Regulatory life cycle for biologicals that are included on the Australian Register of Therapeutic Goods

Part 3 - Access to unapproved biologicals

ARGB appendices

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Appendix 1: Guidelines on Class 2 Biological dossier requirements

Appendix 2: Guidelines on Class 3 Biological dossier requirements

Appendix 3: Guidelines on Class 4 Biological dossier requirements

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

Appendix 5: Guidance on TGO 85 (Standards for human ocular tissue)

Appendix 6: Guidance on TGO 83 (Standards for human musculoskeletal tissue)

Appendix 7: Guidance on TGO 84 (Standards for human cardiovascular tissue)

Appendix 8: Guidance on TGO 86 (Standards for human skin)

Appendix 9: Guidance on TGO 87 (Standards for Labelling)

Appendix 10: Guide to Biologicals Application Form

Appendix 11: Risk management

Appendix 12: Transition arrangements

Appendix 13: Modifying an ARTG entry

Appendix 14: Glossary