Therapeutic Goods Regulations 1990

These regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia.

Official version of legislation
The Federal Register of Legislation is the authorised Australian Government website for Commonwealth legislation. It contains the full text and details of the life cycle of individual laws.

These regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia.

These regulations also set out a number of important elements of the therapeutic goods regulatory scheme in Australia, including:

specifying fees for applying for marketing approval for a therapeutic good or for a manufacturing licence
setting out exemptions from the requirement for therapeutic goods other than medical devices to be included in the Australian Register of Therapeutic Goods (ARTG).

Read the legislation

Guidance referring to this legislation

Manufacturing bacteriophages products in Australia

28 April 2026

Guidance

Guidance on when a manufacturing licence is required for bacteriophage therapy products and how a time-limited Goods Manufacturing Practice exemption will apply. Understand your regulatory obligations when producing bacteriophage products in Australia.
Determining if your content is advertising

7 April 2026

Guidance

This guidance assists entities who disseminate content about therapeutic goods and vaping goods to determine if their material is considered advertising.
Understanding your post-market responsibilities for medical devices

12 March 2026

Guidance

Guidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
Use of legislative powers related to recalls and other market actions

24 February 2026

Guidance

Guidance to help sponsors understand the legislative powers the TGA can use relating to market actions.
Determining the application level for umbrella branded over-the-counter (OTC) medicines

9 February 2026

Guidance

Find out whether your application for an umbrella-branded medicine requires a higher level of assessment.
Understanding requirements for over-the-counter (OTC) new medicine N2 applications

9 February 2026

Guidance

To use the N2 application pathway using OTC medicine monographs, you must ensure that your application meets the requirements for N2 applications.
Exporting medicines from Australia

30 January 2026

Guidance

This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).
Making over-the-counter (OTC) new medicine N1 applications

30 January 2026

Guidance

How to confirm that your OTC application is an N1 application and how to compile the information and assurances for N1 applications.
Becoming an authorised prescriber for unapproved therapeutic goods in Australia

23 December 2025

Guidance

Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.
Understanding listed and registered complementary medicine regulation

16 December 2025

Guidance

Guidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
Instructions for disinfectant testing

7 November 2025

Guidance

Guidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.
Advertising therapeutic goods on social media

5 November 2025

Guidance

This guidance aims to help advertisers understand the legislative requirements for advertising therapeutic goods on social media platforms.
Understanding the legislative framework for listed medicines

30 September 2025

Guidance

Guidance providing an overview of listed medicines and assessed listed medicines pathways and legislative requirements.
Understanding the regulation of therapeutic sunscreens

1 August 2025

Guidance

This guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.
Preparing for Good Clinical Practice (GCP) inspections

2 July 2025

Guidance

Guidance on GCP inspections for clinical trial sites of investigational biologicals, medicines and medical devices regulated under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes.
Changing the sponsor of a therapeutic good

2 July 2025

Guidance

Guidance for what to do if the sponsor of a therapeutic good changes.
Understanding labelling and presentation requirements for listed medicines

9 April 2025

Guidance

Provides guidance on the regulatory requirements for labels and other medicine presentation.
Demonstrating the quality of listed probiotic medicines

25 February 2025

Guidance

Guidance for sponsors and manufacturers to meet the technical, scientific and regulatory requirements to ensure the quality of probiotic medicine acceptable under the Therapeutic Goods Act 1989
Transitioning to new manufacturer evidence for in-vitro diagnostic medical devices (IVDs)

17 January 2025

Guidance

This guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
Understanding fees and charges for prescription medicine applications

19 November 2024

Guidance

Guidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
Understanding Good Manufacturing Practice (GMP) for compounded medicines

18 November 2024

Guidance

Assists in the interpretation of the PIC/S GMP requirements when manufacturing compounded medicines
Providing biopharmaceutic data for medicine applications

12 November 2024

Guidance

Guidance on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.
Understanding requirements for providing a Product Information (PI) document

12 November 2024

Guidance

Guidance on when and how to provide Product Information to us.
Applying for registration of a prescription medicine using the priority pathway

12 November 2024

Guidance

Guidance to assist sponsors to understand the process for submitting a priority registration application.
Submitting an application for a registered complementary medicine

11 November 2024

Guidance

Guidance on the evaluation process and information required for new registered complementary medicines.
Meeting the eligibility criteria for provisional determination

11 November 2024

Guidance

Guidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.
Registering additional trade names for prescription medicines

11 November 2024

Guidance

Guidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines
Meeting the eligibility criteria for priority review determination

8 November 2024

Guidance

This guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.
Applying for provisional registration for a prescription medicine

8 November 2024

Guidance

Guidance on provisional registration process for prescription medicines with provisional determination.
Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: process guidance

5 November 2024

Guidance

Guidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.
Using the Comparable Overseas Bodies process for registered complementary medicines, assessed listed medicines and substances in listed medicines

4 November 2024

Guidance

Guidance on using reports from COBs and submission requirements for evaluation of these applications.
Understanding good manufacturing practice (GMP) for registered medicinal gases

4 November 2024

Guidance

This guidance is for manufacturers of registered medicinal gases to understand our interpretation of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to GMP for medicinal products.
Sampling and testing for listed and complementary medicines

2 November 2024

Guidance

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
Variations to prescription medicines: excluding variations requiring evaluation of clinical or bioequivalence data (for chemical entities)

30 October 2024

Guidance

Guidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data (for biological medicines)

30 October 2024

Guidance

Guidance about the types of notifications and variations for biological medicines.
Applying for new inhalation or nasal spray medicines or changing existing medicines

26 October 2024

Guidance

Guidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.
Understanding the over-the-counter (OTC) new medicines registration process

24 October 2024

Guidance

This guidance explains requirements for registering a non-prescription OTC medicine on the Australian Register of Therapeutic Goods (ARTG).
Understanding our pharmacovigilance inspection program (PVIP) for medicines

24 October 2024

Guidance

This guidance will help you understand our pharmacovigilance inspection program (PVIP).
Apply for orphan drug designation for a prescription medicine

23 October 2024

Guidance

Guidance for sponsors about how to apply for orphan drug designation for a prescription medicine.
Using modified unprocessed herbal materials in complementary medicines

23 October 2024

Guidance

Guidance on the use of modified unprocessed herbal materials in complementary medicines
Making an offer of enforceable undertaking for compliance

23 October 2024

Guidance

Guidance for making an offer of enforceable undertaking to us.
Understanding timeframes for the Comparable Overseas Bodies process for registered complementary medicines, assessed listed medicines and substances in listed medicines

22 October 2024

Guidance

Guidance explaining how the Comparable Overseas Bodies report-based process is associated with shortened evaluation timeframes for applications.
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.
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
Advertising mushroom products that are therapeutic goods

17 October 2024

Guidance

Guidance on complying with therapeutic goods advertising requirements.
Understanding quality requirements for listed medicines

17 October 2024

Guidance

Guidance for sponsors on the information required to establish quality for listed medicines.
Manufacturing sunscreen and complying with Good Manufacturing Practice (GMP)

15 October 2024

Guidance

Guidance for sunscreen manufacturers who must comply with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-13).
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).
Manufacturing faecal microbiota transplant (FMT) products

14 October 2024

Guidance

Guidance for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products.
Requesting the Minister for Health to reconsider our initial decision

14 October 2024

Guidance

Guidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
Applying for priority determination for a prescription medicine

11 October 2024

Guidance

Guidance about the process of applying for a priority determination, which is the first step of the priority review registration pathway.
Meeting the eligibility criteria for orphan drug designation

11 October 2024

Guidance

Guidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.
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.
Supplying unapproved therapeutic goods as a sponsor

10 October 2024

Guidance

This guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.
Managing conflicts of interest and confidentiality obligations on advisory committees

9 October 2024

Guidance

Guidance on declaring and managing conflicts of interest and confidentiality obligations for TGA advisory committee members.
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.
Applying the Advertising Code rules: prominently displayed or communicated information

4 October 2024

Guidance

This guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.
Applying for provisional determination for a prescription medicine

4 October 2024

Guidance

Guidance on applying for a provisional determination, which is the first step of the provisional approval pathway.
Australian clinical trial handbook

3 October 2024

Guidance

Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.
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.
Applying the Advertising Code rules: restricted representations

3 October 2024

Guidance

This Guidance explains part 8 of the Code, which outlines rules for making restricted representations when advertising therapeutic goods.
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.
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.
Requesting early scientific advice on a biowaiver justification

2 October 2024

Guidance

Guidance on how to request early scientific advice on a biowaiver justification.
Using assessments from comparable overseas regulators (CORs) for prescription medicines

1 October 2024

Guidance

Guidance on how we make use of assessments from comparable overseas regulators (CORs).
Changing a listed or an assessed listed medicine in the Australian Register of Therapeutic Goods (ARTG)

1 October 2024

Guidance

Guidance on changing information in the ARTG for listed or assessed listed medicines.
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).
Understanding rules for exempt disinfectants in Australia

30 September 2024

Guidance

Guidance on how exempt disinfectants are defined and meeting the regulatory requirements for their manufacture, supply and advertising.
Meeting regulatory requirements for menstrual cups in Australia

30 September 2024

Guidance

How to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.
Preparing Consumer Medicine Information (CMI) documents for medicines

30 September 2024

Guidance

This guidance provides information about preparing Consumer Medicine Information (CMI) documents that comply with current regulations.
Completing a Declaration of Conformity for Class 1 medical devices

30 September 2024

Guidance

Guidance detailing self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.
Understanding the different evaluation pathways for medicines

30 September 2024

Guidance

Guidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.
Applying for the Annual Charges Exemption scheme

26 September 2024

Guidance

Guidance about the Annual Charge Exemption (ACE) scheme waiver process.
Applying for a fee reduction for a prescription medicine major variation application

26 September 2024

Guidance

Guidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
Understanding over-the-counter (OTC) generic and originator medicines

26 September 2024

Guidance

Guidance on generic and originator medicines in the context of over-the-counter (OTC) non-prescription medicine applications.
Using a Boxed Warning in Product Information (PI) or Consumer Medicine Information (CMI)

25 September 2024

Guidance

Guidance for sponsors on how and when to use a boxed warning in PI or a CMI.
Performing product quality reviews (PQRs) for listed and complementary medicines

25 September 2024

Guidance

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
Completing a declaration of conformity for system or procedure packs

25 September 2024

Guidance

This guidance applies to manufacturers of medical devices that are regulated as system or procedure packs and supplied using the special conformity assessment procedure regulatory pathway.
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.
Accessing MDMA (3,4-methylenedioxy-methamphetamine) and psilocybine as a psychiatrist

24 September 2024

Guidance

This guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybine from 1 July 2023.
Classifying biologicals

24 September 2024

Guidance

Australian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.
Understanding regulation of disinfectants, sterilants and sanitary products

23 September 2024

Guidance

Guidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
Advertising intravenous (IV) drip therapies

23 September 2024

Guidance

This guidance assists providers of IV drips to understand how to comply with the therapeutic goods advertising requirements in Australia.
Importing, manufacturing and supplying medicinal cannabis in Australia

23 September 2024

Guidance

Guidance for importation, supply and wholesale requirements for medicinal cannabis.
Substituting equivalent herbal extract ingredients in listed medicines

23 September 2024

Guidance

Guidance on equivalence of herbal extracts in complementary medicines.
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.
Advertising medicinal cannabis products is prohibited

23 September 2024

Guidance

If your business is involved with medicinal cannabis products or health services involving medicinal cannabis, this guidance will help ensure you do not unlawfully advertise medicinal cannabis to consumers. This includes through the promotion of your business or services.
Supplying, importing and exporting disinfectant products

23 September 2024

Guidance

Guidance for new sponsors on how to supply, import, and export disinfectant products.
Providing a sponsor notice to import or supply therapeutic vaping goods in Australia

10 September 2024

Guidance

From 1 March 2024, a sponsor notice must be given by a sponsor of a vaping good to the TGA before the good is imported into, or supplied in, Australia following domestic manufacture.
Understanding the regulation of listed disinfectants in Australia

6 July 2023

Guidance

Guidance about how we define and regulate listed disinfectants, including how to submit a product application and the supporting data and other information required.
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
Understanding biologicals (priority applicant) determination

30 November 2022

Guidance

This guidance is for sponsors intending to use the priority review pathway for biologicals.
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.
Applying the Advertising Code rules: testimonials and endorsements

1 June 2022

Guidance

This guidance explains part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.
Prescription medicines registration process

12 August 2021

Guidance

Guidance on the process and regulatory requirements to register prescription medicines.
Understanding serialisation and data matrix codes on medicines

26 March 2021

Guidance

This guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes.
Manufacturing COVID-19 medical devices and components, including 3D printing

28 January 2021

Guidance

Guidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
Applying for provisional registration extension or transition to full registration

21 January 2021

Guidance

Guidance on obligations during provisional registration period, process for applying for extension of provisional registration and transition to full registration.
Changing a registered complementary medicine RCM: application levels and changes tables

20 May 2020

Guidance

Guidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
TGA approved terminology for therapeutic goods

1 March 2020

Guidance

Guidance on our approved terminology for medicines.
Understanding the different types of complementary medicines

3 May 2018

Guidance

Guidance to help you understand the different types of complementary medicines.

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Legislation

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Therapeutic Goods Regulations 1990

Official version of legislation

Guidance referring to this legislation