Australian regulatory guidelines for biologicals (ARGB)

13 February 2014

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 and use of human cell and tissue-based therapeutic goods (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

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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

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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)

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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

Not yet available

Appendix 14: Glossary

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AttachmentSize
Australian regulatory guidelines for biologicals, Appendix 1 – Guidelines on Class 2 Biological dossier requirements (docx)6MB
Australian regulatory guidelines for biologicals, Appendix 1 – Guidelines on Class 2 Biological dossier requirements (pdf)320KB
Australian regulatory guidelines for biologicals, Appendix 2 – Guidelines on Class 3 Biological dossier requirements (docx)6MB
Australian regulatory guidelines for biologicals, Appendix 2 – Guidelines on Class 3 Biological dossier requirements (pdf)378KB
Australian regulatory guidelines for biologicals, Appendix 3 – Guidelines on Class 4 Biological dossier requirements (docx)6MB
Australian regulatory guidelines for biologicals, Appendix 3 – Guidelines on Class 4 Biological dossier requirements (pdf)378KB
(docx)673KB
(pdf)355KB
Australian regulatory guidelines for biologicals, Appendix 5 – Guidance on TGO 85 (Standards for human ocular tissue) (docx)5MB
Australian regulatory guidelines for biologicals, Appendix 5 – Guidance on TGO 85 (Standards for human ocular tissue) (pdf)263KB
Australian regulatory guidelines for biologicals, Appendix 6 – Guidance on TGO 83 (Standards for human musculoskeletal tissue) (docx)5MB
Australian regulatory guidelines for biologicals, Appendix 6 – Guidance on TGO 83 (Standards for human musculoskeletal tissue) (pdf)253KB
Australian regulatory guidelines for biologicals, Appendix 7 – Guidance on TGO 84 (Standards for human cardiovascular tissue) (docx)5MB
Australian regulatory guidelines for biologicals, Appendix 7 – Guidance on TGO 84 (Standards for human cardiovascular tissue) (pdf)247KB
Australian regulatory guidelines for biologicals, Appendix 8 – Guidance on TGO 86 (Standards for human skin) (docx)5MB
Australian regulatory guidelines for biologicals, Appendix 8 – Guidance on TGO 86 (Standards for human skin) (pdf)242KB
Australian regulatory guidelines for biologicals, Appendix 9 – Guidance on TGO 87 (General requirements for the labelling of biologicals) (docx)5MB
Australian regulatory guidelines for biologicals, Appendix 9 – Guidance on TGO 87 (General requirements for the labelling of biologicals) (pdf)255KB
Australian regulatory guidelines for biologicals, Appendix 10 – Guide to Biologicals application form (docx)9MB
Australian regulatory guidelines for biologicals, Appendix 10 – Guide to Biologicals application form (pdf)1MB
Australian regulatory guidelines for biologicals, Appendix 11 - Risk Management (docx)6MB
Australian regulatory guidelines for biologicals, Appendix 11 - Risk Management (pdf)321KB
Australian regulatory guidelines for biologicals, Appendix 12 – Transition arrangements (docx)5MB
Australian regulatory guidelines for biologicals, Appendix 12 – Transition arrangements (pdf)238KB
Australian regulatory guidelines for biologicals, Appendix 14 - Glossary (docx)6MB
Australian regulatory guidelines for biologicals, Appendix 14 - Glossary (pdf)251KB
Australian regulatory guidelines for biologicals, Part 1 - Introduction to the Australian regulatory guidelines for biologicals (docx)6MB
Australian regulatory guidelines for biologicals, Part 1 - Introduction to the Australian regulatory guidelines for biologicals (pdf)478KB
Australian regulatory guidelines for biologicals, Part 2 - Regulatory life cycle for biologicals that are included on the Australian Register of Therapeutic Goods (docx)6MB
Australian regulatory guidelines for biologicals, Part 2 - Regulatory life cycle for biologicals that are included on the Australian Register of Therapeutic Goods (pdf)405KB
Australian regulatory guidelines for biologicals, Part 3 - Access to unapproved biologicals (docx)6MB
Australian regulatory guidelines for biologicals, Part 3 - Access to unapproved biologicals (pdf)293KB