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Australian regulatory guidelines for biologicals (ARGB)
Forms
5 July 2019
The Australian Regulatory Guidelines for Biologicals (ARGB):
- provides information on the supply and use of human cell and tissue-based therapeutic goods, and live animal cells, tissues and organs
- explains the legislative requirements outlined in the regulatory framework for biologicals, including specific biological standards.
Pathways for supply of biologicals
If you have a product that meets our definition of a biological, Pathways for supply of biologicals will help you understand how your biological can be supplied.
Updates
ARGB updated
27 July 2018
The Australian Regulatory Guidelines for Biologicals has been restructured and updated in line with new legislative changes
ARGB
Classification & regulation
- What is regulated as a biological?
- Autologous human cells and tissues (HCTs) products regulation
- Classification of biologicals
Supply of biologicals
- Unapproved biologicals: pathways for access
- Applying for inclusion of a Class 2, 3 or 4 biological on the ARTG
- Manufacturing biologicals
Post-market requirements
Regulation basics
- What is regulated as a biological
Understand our definition of a biological and how they are regulated - Pathways for supply of biologicals
Supply pathways differ for products regulated as biologicals depending on whether they are exempt, 'unapproved' or included on the ARTG - Biologicals packaged or combined with another therapeutic good
Understand the regulatory requirements when a biological is supplied with another product - Glossary
Definitions of terms used throughout the ARGB and TGA website
Classification and interpretation
- Classification of biologicals
All biologicals must be classified before being included on the ARTG - Method of preparation: Interpretation of minimal manipulation
The method of preparation influences classification and whether autologous HCT products are eligible for exemptions - Intended use: Interpretation of homologous use
The intended use influences classification and whether autologous HCT products are eligible for exemptions - Request for TGA advice on classification
Form to assist with classification of your biological product and to complete when requesting advise on classification from us
Autologous human cells and tissues (HCT) products
- Autologous human cells and tissues products regulation
Risk-based regulatory approach and criteria for exemptions and exclusions criteria- Excluded autologous human cells and tissues
Exclusion criteria with examples of products likely to be excluded - Exempt autologous human cells and tissues
Exemption criteria and the regulatory requirements that still apply
- Excluded autologous human cells and tissues
- Transition arrangements
Some exemptions apply until 30 June 2019. This page explains whether they apply to your product and what you need to do - Regulation of platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and conditioned serum
These products are usually considered blood components and regulated as medicines, not as biologicals
Administrative information
- TGA Business Services: getting started with the TGA
Introduction to TGA online services for sponsors, agents and manufacturers - Drafter and submitter guidance: using TGA business services for applications
A guide to some of the features of TGA Business Services used by drafters and submitters of applications - Fees and charges summary
Current fees and charges
Access to unapproved biologicals
- Unapproved biologicals: pathways for access
'Unapproved' biologicals refer to those goods that have not been included on the ARTG. Access pathways include clinical trials, special access and authorised prescriber schemes.
Applying for inclusion on the ARTG
- Preparing your biologicals application for inclusion in the ARTG
Understand what you need to do before submitting an application for inclusion of a biological on the ARTG - Separate and distinct biologicals
Determine whether your products are separate and distinct biologicals and if they require separate entries on the ARTG - Dossier requirements for Class 2, 3 and 4 biologicals
Understand what to include in your dossier to submit with your application - Applying for inclusion of a Class 2, 3 or 4 biological on the ARTG - a step-by-step guide
How to prepare and submit an application - Applying for inclusion of a Class 1 biological on the ARTG
Process for Class 1 biologicals to be included on the ARTG - Biologicals application form - a step by step guide
Accessing and completing the application form to include or vary a biological on the ARTG - Manufacturing biologicals
Understand the different manufacturing principles that apply to different kinds of biologicals, the licensing requirements and your responsibilities - Risk management plans for biologicals
Understand the risk management system required to identify, characterise and minimise a product's risks
Post-market responsibilities
- Post-market responsibilities (biologicals)
Activities that must be maintained after approval to supply a biological - Varying biological entries on the ARTG
For changes to matters that would have been relevant to the initial decision to include the biological in the ARTG, you need to request and receive our approval - Notifications for included biologicals
Certain changes may be made to an ARTG entry through the notification process where quality, safety and efficacy are not affected - Adverse event reporting and biovigilance responsibilities
Understand mandatory reporting and record-keeping requirements - Uniform recall procedure for therapeutic goods
The uniform recall procedure for therapeutic goods (URPTG) applies to biologicals - Australian regulatory guidelines for advertising therapeutic goods
Understand the advertising restrictions that apply to biologicals and autologous HCTs - Exceptional release of biologicals included on the ARTG
Release on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient
Below are links to guidance on each of the product-specific standards to assist you in ensuring your products conform with the relevant standards.
- ARGB 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
- ARGB Appendix 5: Guidance on TGO 85 (Standards for human ocular tissue)
- ARGB Appendix 6: Guidance on TGO 83 (Standards for human musculoskeletal tissue)
- ARGB Appendix 7: Guidance on TGO 84 (Standards for human cardiovascular tissue)
- ARGB Appendix 8: Guidance on TGO 86 (Standards for human skin)
- ARGB Appendix 9: Guidance on TGO 87 (Standards for Labelling)