Australian Regulatory Guidelines for Biologicals (ARGB)

Regulation basics

• Understanding which therapeutic goods are regulated as biologicals

  30 September 2024

  Guidance

  Guidance to help you understand which therapeutic goods will be regulated as a biological.

• Pathways for supply of biologicals

  27 July 2018

  Page

  Understand that not everything meeting our definition of a biological is regulated as a biological.

• Supplying biologicals packaged or combined with other therapeutic goods

  1 October 2024

  Guidance

  Guidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.

• Acronyms and glossary terms

  Definition type

  View terms and acronyms commonly used in Australian therapeutic goods regulation, and their definitions. This list is intended for general informational purposes and is not exhaustive.

Classification

• Classifying biologicals

  24 September 2024

  Guidance

  Australian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.

• Understanding the minimal manipulation method of preparation for biologicals

  21 October 2024

  Guidance

  Guidance explaining how the method of preparation influences classification and whether autologous HCTs are eligible for exemptions.

• Determining if a biological product is for homologous use

  3 October 2024

  Guidance

  Guidance to explain how the intended use of a biological product influences its classification and exemptions.

• Request for advice - Biologicals

  6 January 2020

  Forms

  This form guides you through the classification of biologicals and captures sufficient information about your product for us to provide advice

Manufacturing

• Manufacturing biologicals

  9 May 2025

  Page

  This page is for manufacturers of biologicals

Applying for inclusion on the Australian Register of Therapeutic Goods (ARTG)

• Preparing your biologicals application for inclusion in the Australian Register of Therapeutic Goods (ARTG)

  21 June 2022

  Guidance

  An outline of the regulatory process and a summary of the requirements to successfully submit a biologicals application.

• Determining if your products are separate and distinct biologicals

  9 October 2024

  Guidance

  Guidance to help determine whether products are separate and distinct biologicals that will need to be included as separate ARTG entries.

• Dossier requirements for Class 2, 3 and 4 biologicals

  1 July 2018

  Guidance

  This guidance outlines the information needed in your dossier for us to be able to effectively review your application for a biological therapeutic good.

• Applying for inclusion of Class 2, 3 or 4 biological on the Australian Register of Therapeutic Goods (ARTG)

  21 June 2022

  Guidance

  Guidance on the stages of preparing and submitting an application for inclusion of a Class 2, 3 or 4 biological in the ARTG.

• Applying for a Class 1 biological to be added in the Australian Register of Therapeutic Goods (ARTG)

  23 September 2024

  Guidance

  Guidance for preparing and submitting an application for inclusion of a Class 1 biological on the ARTG.

• Biologicals application form - a step-by-step guide

  30 November 2022

  User guide

  This form is used to include a new biological or vary an existing biological on the ARTG

• Submitting risk management plans for medicines and biologicals

  1 March 2019

  Guidance

  Risk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form.

• Consent to import, supply or export therapeutic goods that do not comply with standards - information for industry

  4 February 2025

  Page

  Medicines and other therapeutic goods must comply with applicable standards to be supplied in Australia.

Biologicals priority determination

• Priority review pathway for biologicals

  30 November 2022

  Page

  Information on the stages of preparation, and application for Class 2, 3 or 4 biologicals using priority pathway.

• Meeting the eligibility criteria for priority determination applications: biologicals

  21 October 2024

  Guidance

  Guidance for biological sponsors on the eligibility criteria and supporting documents required for priority determination applications

• Understanding biologicals (priority applicant) determination

  30 November 2022

  Guidance

  This guidance is for sponsors intending to use the priority review pathway for biologicals.

Autologous human cells and tissues (HCT) products

• Understanding regulation of autologous human cell and tissue (HCT) products

  24 September 2024

  Guidance

  Guidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.

• Manufacturing excluded autologous human cell and tissue (HCT) products

  3 October 2024

  Guidance

  Guidance to help work out if your autologous HCT product is excluded from our regulation.

• Manufacturing exempt autologous human cell and tissue (HCT) products

  3 October 2024

  Guidance

  Guidance to help work out if your autologous HCT product is exempt from some aspects of our regulation.

• Regulating platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and conditioned serum

  30 September 2024

  Guidance

  Guidance to determine the level of regulation of PRP, PRF or conditioned serum products for therapeutic use.

Unapproved biologicals

• Accessing unapproved biologicals that are not on the Australian Register of Therapeutic Goods (ARTG)

  1 October 2024

  Guidance

  Guidance for people who want to access biologicals that are not included on the Australian Register of Therapeutic Goods (ARTG).

Post-market responsibilities

• Understanding your post-market responsibilities for biologicals

  15 October 2024

  Guidance

  Guidance for sponsors or suppliers of biologicals in Australia on their ongoing responsibilities after a product is included on the Australian Register. of Therapeutic Goods (ARTG).

• Varying biological entries on the ARTG

  25 May 2023

  Guidance

  This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biological

• Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected

  23 May 2023

  Guidance

  Guidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.

• Biovigilance responsibilities of sponsors of biologicals

  1 December 2017

  Guidance

  This guidance is for all sponsors of products regulated as biologicals.

• Procedure for recalls, product alerts and product corrections (PRAC)

  5 March 2025

  Page

  Information for sponsors conducting market actions for therapeutic goods in Australia.

• Advertising stem cell and other human cell or tissue (HCT) products

  23 September 2024

  Guidance

  Guidance about how to promote your business and service, without advertising biologicals to the public.

• Requesting an exceptional release for non-conforming biologicals

  3 October 2024

  Guidance

  Release on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient. Access to the request form and instructions are within the guidance document.

• Understanding rules for labelling biologicals

  8 October 2024

  Guidance

  Guidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.

Biologicals standards

• Therapeutic Goods (Standard for Faecal Microbiota Transplant Products) (TGO 105) Order 2020

  Legislation

  This Therapeutic Goods Order constitutes a standard for faecal microbiota transplant products.

• Therapeutic Goods (Standard for Biologicals—Labelling Requirements) (TGO 107) Order 2021

  Legislation

  This Therapeutic Goods Order constitutes a standard for biologicals in relation to labelling.

• Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order 2021

  Legislation

  The Order establishes mandatory requirements for the screening of donors of human cell and tissue products in Australia to ensure the safety, quality, and efficacy of these products for therapeutic use.

• Therapeutic Goods (Standards for Biologicals—General and Specific Requirements) (TGO 109) Order 2021

  Legislation

  This Therapeutic Goods Order sets out general and specific requirements relating to all biologicals, human musculoskeletal tissue products, human cardiovascular tissue products, human ocular tissue products, human skin products and human amnion products.

• Understanding rules for labelling biologicals

  8 October 2024

  Guidance

  Guidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.

• Understanding donor screening rules for human cell or tissue products

  4 November 2024

  Guidance

  Guidance on TGO 108: Requirements around the minimisation of transmission of communicable diseases for therapeutic goods containing biologicals and human cell or tissue (HCT).

• Understanding rules for manufacturing biologicals

  4 November 2024

  Guidance

  Guidance on TGO 109: Standards for Biologicals - General and Specific Requirements.

• Understanding standards for faecal microbiota transplant (FMT) products

  30 September 2024

  Guidance

  This guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in TGO 105.

• Supplying faecal microbiota transplant (FMT) products as biologicals

  11 October 2024

  Guidance

  Guidance for sponsors of faecal microbiota transplant (FMT) products, which are regulated as biologicals.

• Faecal microbiota transplant products regulation

  4 August 2023

  Page

  Understand how we regulate faecal microbiota transplant (FMT) products.

Business services

• TGA Business Services: getting started with the TGA

  30 June 2021

  Page

  Apply for access and manage your account details.

• TGA Business Services - questions and answers for drafters/submitters

  27 April 2015

  User guide

  Questions and answers for drafters/submitters

• Summary of fees and charges to applications submitted to the TGA

  27 June 2025

  Page

  Find out about fees and charges that apply from January 2025