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
23 June 2021
There have been recent changes to the process for Class 1 biological applications. The ARGB pages for Applying for inclusion of a Class 1 biological on the ARTG and Biologicals application form - a step by step guide have been updated to reflect these changes.
See more updates
ARGB updated
26 May 2021
The Therapeutic Goods Administration (TGA) is conducting a public consultation seeking feedback on a proposal to remake some of the legislative instruments and associated guidance documents relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021.
For more information on the proposals, and to participate in the consultation, please visit the consultation hub
ARGB updated
6 January 2020
There have been recent changes to the regulation of FMT products. The Australian Regulatory Guidelines for Biologicals has been updated to reflect these changes.
27 July 2018
The Australian Regulatory Guidelines for Biologicals has been restructured and updated in line with new legislative changes
TGA presentation: Changes to the regulation of autologous human cells and tissue products
20 June 2018
An overview of the changes to the regulation of autologous HCT, including guidance on restrictions to advertising content and the need to report adverse events
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
- Varying biological entries on the ARTG
- Reporting an adverse event
- Initiating a product recall or hazard alert
- Australian regulatory guidelines for advertising therapeutic goods
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
- 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
Faecal Microbiota Transplant (FMT) products
- Faecal Microbiota Transplant (FMT) product regulation
All FMT products are regulated 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 - Consent to import, supply or export therapeutic goods that do not comply with standards
From 1 July 2020, a fee applies for the processing of applications for consent for biologicals under section 14 the Therapeutic Goods Act 1989
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 - Advertising guidance for businesses involved with stem cells and other human cell or tissue (HCT) products
This guidance is to assist providers of stem cells and other human cell and tissue (HCT) products regulated as biologicals (including sponsors, manufacturers, importers, pharmacists, health professionals and marketers) in complying with the therapeutic goods advertising restrictions - 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 10: Guidance on TGO 105: Standards for faecal microbiota transplant (FMT) products
- ARGB Appendix 11: Guidance on Therapeutic Goods (Standard for Biologicals - Labelling Requirements) (TGO 107) Order 2021
- ARGB Appendix 12: Guidance on Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Screening Requirements) (TGO 108) Order 2021
- ARGB Appendix 13: Guidance on Therapeutic Goods (Standards for Biological - General and Specific Requirements) (TGO 109) Order 2021