The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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 - Procedure for recalls, product alerts and product corrections (PRAC)
The procedure for recalls, product alerts and product corrections (PRAC) 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