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Australian regulatory guidelines for biologicals (ARGB)

29 August 2011

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:

• Email: bloodandtissues@tga.gov.au
• Phone: 1800 678 799 (freecall within Australia)

ARGB

How to access a pdf or Word document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

ARGB parts

Part 1 - Introduction to the Australian Regulatory Guidelines for Biologicals

• Australian Regulatory Guidelines for Biologicals, Part 1 - Introduction to the Australian Regulatory Guidelines for Biologicals (pdf,479kb)
• Australian Regulatory Guidelines for Biologicals, Part 1 - Introduction to the Australian Regulatory Guidelines for Biologicals (Microsoft Word,6.08Mb)*

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

• Australian Regulatory Guidelines for Biologicals, Part 2 - Regulatory life cycle for biologicals that are included on the Australian Register of Therapeutic Goods (pdf,406kb)
• Australian Regulatory Guidelines for Biologicals, Part 2 - Regulatory life cycle for biologicals that are included on the Australian Register of Therapeutic Goods (Microsoft Word,6.06Mb)*

Part 3 - Access to unapproved biologicals

• Australian Regulatory Guidelines for Biologicals, Part 3 - Access to unapproved biologicals (pdf,294kb)
• Australian Regulatory Guidelines for Biologicals, Part 3 - Access to unapproved biologicals (Microsoft Word,6.43Mb)*

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ARGB appendices

How to access a pdf or Word document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

Appendix 1: Guidelines on Class 2 Biological dossier requirements

• ARGB Appendix 1: Guidelines on Class 2 Biological dossier requirements (pdf,320kb)
• ARGB Appendix 1: Guidelines on Class 2 Biological dossier requirements (Microsoft Word,5.70Mb)*

Appendix 2: Guidelines on Class 3 Biological dossier requirements

• ARGB Appendix 2: Guidelines on Class 3 Biological dossier requirements (pdf,379kb)
• ARGB Appendix 2: Guidelines on Class 3 Biological dossier requirements (Microsoft Word,5.71Mb)*

Appendix 3: Guidelines on Class 4 Biological dossier requirements

• ARGB Appendix 3: Guidelines on Class 4 Biological dossier requirements (pdf,379kb)
• ARGB Appendix 3: Guidelines on Class 4 Biological dossier requirements (Microsoft Word,5.71Mb)*

Appendix 4: Guidance on 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

• ARGB Appendix 4: Guidance on 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 (pdf,492kb) 
• ARGB Appendix 4: Guidance on 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 (Microsoft Word,6.27Mb)*

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

• ARGB Appendix 5: Guidance on TGO 85 (Standards for human ocular tissue) (pdf,264kb)
• ARGB Appendix 5: Guidance on TGO 85 (Standards for human ocular tissue) (Microsoft Word,5.27Mb)*

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

• ARGB Appendix 6: Guidance on TGO 83 (Standards for human musculoskeletal tissue) (pdf,253kb)
• ARGB Appendix 6: Guidance on TGO 83 (Standards for human musculoskeletal tissue) (Microsoft Word,5.29Mb)*

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

• ARGB Appendix 7: Guidance on TGO 84 (Standards for human cardiovascular tissue) (pdf,248kb)
• ARGB Appendix 7: Guidance on TGO 84 (Standards for human cardiovascular tissue) (Microsoft Word,5.28Mb)*

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

• ARGB Appendix 8: Guidance on TGO 86 (Standards for human skin) (pdf,242kb)
• ARGB Appendix 8: Guidance on TGO 86 (Standards for human skin) (Microsoft Word,5.27Mb)*

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

• ARGB Appendix 9: Guidance on TGO 87 (Standards for Labelling) (pdf,256kb)
• ARGB Appendix 9: Guidance on TGO 87 (Standards for Labelling) (Microsoft Word,5.26Mb)*

Appendix 10: Guide to Biologicals Application Form

• ARGB Appendix 10: Guide to Biologicals application form (pdf,1.16Mb)*
• ARGB Appendix 10: Guide to Biologicals application form (Microsoft word,8.59Mb)*

Appendix 11: Risk management

• ARGB Appendix 11: Risk management (pdf,322kb)
• ARGB Appendix 11: Risk management (Microsoft Word,5.70Mb)*

Appendix 12: Transition arrangements

• ARGB Appendix 12: Transition arrangements (pdf,239kb)
• ARGB Appendix 12: Transition arrangements (Microsoft Word,5.26Mb)*

Appendix 13: Modifying an ARTG entry

Not yet available

Appendix 14: Glossary

• ARGB Appendix 14: Glossary (pdf,251kb)
• ARGB Appendix 14: Glossary (Microsoft Word,5.68Mb)*

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