Therapeutic Goods Act 1989

Guidance on the regulatory requirements for assessed listed medicines.

Guidance on changing information in the ARTG for listed or assessed listed medicines.

Guidance to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices.

Guidance explaining the regulatory requirements for listed medicines and how we undertake compliance reviews.

Guidance providing an overview of listed medicines and listed assessed medicines pathways and legislative requirements.

Guidelines for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.

Guidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).

Guidance on how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).

Guidance about how to advertise therapeutic goods exclusively to health professionals.

Guidance on complying with therapeutic goods advertising requirements.

The trade name of a therapeutic good must comply with therapeutic goods legislation, including advertising legislation.

Guidance and examples to help you understand the regulatory framework for personalised medical devices.

Guidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.

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

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).

Guidance for sponsors of antibiotics on collecting and providing pre- and post-market information about antibiotic resistance.

Guidance on understanding the rules for advertising therapeutic goods to consumers

Guidance on reporting adverse events for sponsors of medical devices.

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

Guidance on advertising services that involve therapeutic goods.

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.

Information on the rules governing COVID-19 rapid antigen tests (RATs) advertising.

Guidance on preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).

Guidance to understand if your medical device product should be in the ARTG.

Guidance on interpretation of software exclusion criteria to understand the boundaries between software that is and is not regulated.

Guidance on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.

Guidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.

Guidance to help manufacturers of medical devices classify their devices correctly.

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

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.

Guidance to assist Australian corporations seeking to apply for an Australian conformity assessment body (CAB) determination for medical devices (including IVDs) by the TGA.

This guidance explains good manufacturing practice (GMP) requirements for Australian sponsors and manufacturers of medicines, active pharmaceutical ingredients (APIs) and sunscreens.

Clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA's Good Clinical Practice (GCP) inspection program.

This guidance will assist you in determining if a product is a cosmetic or a therapeutic good and how to comply with Australian regulatory requirements and advertising rules for therapeutic goods.

Find out how TGA regulates software and artificial intelligence (AI) based medical devices.

Guidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).

This guidance helps Australian health practitioners, that manufacture, supply, and use medical devices, to understand whether you are regulated by us, and how to comply.

Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.

How to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.

This guidance outlines ARTG and conformity assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know.

Guidance on the transitional arrangements and obligations of sponsors and manufacturers.

Guidance on the transitional arrangements and obligations.

Guidance on the transitional arrangements and obligations of medical devices with a diagnostic function.

This guidance assists providers of IV drips to understand how to comply with the therapeutic goods advertising requirements in Australia.

Guidance on clinical performance requirements and risk mitigation strategies.

Guidance to explain what we need for software and apps that work with COVID-19 rapid antigen tests.

Guidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.

Guidance about the regulation of sport supplements in Australia for importers and sellers.

This guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.

Guidance on the use of a medical device in a way that is not included in the intended purpose in the Australian Register of Therapeutic Goods (ARTG), and rules for advertising off-label uses.

Guidance on the information that we include in AusPARS for prescription medicines and when we publish them.

Guidance to assist sponsors and manufacturers when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG) and selecting a GMDN term.

Guidance about the types of notifications and variations for biological medicines.

Guidance for sponsors who have submitted applications for inclusion of medical devices including in-vitro diagnostics (IVDs), in the Australian Register of Therapeutic Goods (ARTG).

Guidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.

This guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations.

This guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).

Guidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.

This guidance will assist companies making announcements, to comply with their continuous disclosure obligations, without advertising therapeutic goods to the public.

Guidance and other resources for sponsors about mandatory reporting of medicine shortages in Australia.

Guidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.

Guidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations, and our approach to compliance.

Guidance for supplying substitute medicines when registered medicines are unavailable or in short supply.

Guidance on the application process and information required for a substance to be evaluated for use in listed medicines.

Mandatory labelling requirements for biologicals and human cell and tissue materials.

Guidance on the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma

Guidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.

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

Guidance for importation, supply and wholesale requirements for medicinal cannabis.

Guidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.

Guidance on how to provide the required patient information materials with all implantable and active implantable medical devices.

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.

Guidance for preparing a technical file review, as part of your application to include an in-vitro medical device in the Australian Register of Therapeutic Goods.

Guidance applies to self-tests and point-of-care combo test kits.

Guidance on medical device application processing timeframes.

This guidance aims to help advertisers apply the legislative requirements for advertising therapeutic goods on social media platforms.

Guidance for sponsors and manufacturers on regulatory responsibilities associated with first aid kits supplied using the special conformity assessment procedure.

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.

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.

Guidance to assist sponsors with the reclassification of surgical mesh devices.

This guidance document provides information about when and how clinical decision support software is regulated in Australia by the TGA.

An overview of the Data Protection Scheme for assessed listed medicines, and the criteria that must be met for information to be considered protected under the Scheme.

Guidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.

Guidance for notifying the TGA about substantial changes to, or transfers of, conformity assessment certificates.

Guidance on the process and regulatory requirements to register prescription medicines.

Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.

Information to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.

Guidance about evidence required to substantiate the quality of the product, for over-the-counter (OTC) medicine registration applications.

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

Guidance on good manufacturing practice (GMP) compliance requirements for domestic and overseas manufacturers of medicines and biologicals.

Guidance on how exempt disinfectants are defined and meeting the regulatory requirements for their manufacture, supply and advertising.

Guidance for sponsors on the process for including IVD medical devices in the ARTG.

Guidance to help manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.

This guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes.

Guidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.

This guidance explains the administrative and prescribing (dossier) information you need to support the registration of a prescription medicine. It also applies to varying the details of an Australian Register of Therapeutic Goods (ARTG) registration for a prescription medicine.

Guidance on the priority applicant determination criteria and process for medical devices including in vitro diagnostics (IVDs).

Guidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed medicines.

Guidance for sponsors and manufacturers about medical device definitions and requirements for system or procedure packs.

Guidance on how to request early scientific advice on a biowaiver justification.

Guidance for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products.

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

Guidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.

This guidance explains requirements for registering a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).

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

Guidance on the evaluation process and information required for new registered complementary medicines.

Guidance on using literature based submissions for applications for listed, assessed listed and registered complementary medicines.

Information required to establish quality for listed medicines

Guidance to understand how we interpret regulations and how manufacturers can comply with them.

Guidance on our approved terminology for medicines.

Guidance to assist sponsors and manufacturers of medicinal cannabis products to conform with TGO 100.

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

Guidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.

Guidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.

Guidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).

Guidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.

Guidance for making an offer of enforceable undertaking to us.

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

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

Guidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.

Guidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13.

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

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

Guidance for the requirements applicable to medical devices containing poisons.

Guidance for manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format.

Guidance about the process of applying for a priority determination, which is the first step of the priority review registration pathway.

Guidance on provisional registration process for prescription medicines with provisional determination.

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).

Guidance on how we make use of assessments from comparable overseas regulators (CORs).

Guidance to change an ARTG registered over-the-counter (OTC) medicine.

Guidance for manufacturers and sponsors on the product standards that apply to haematopoietic progenitor cells (HPCs).

This guidance will help you understand our pharmacovigilance inspection program (PVIP).

This guidance describes the safety and efficacy data you will need for CTD Module 4 and Module 5 to support applications to either register an OTC medicine in the ARTG or vary the safety and/or efficacy aspects of a registered OTC medicine. (Formerly ARGOM Appendix 1)

Guidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines

Guidance on the two mechanisms to provide information about a drug substance sourced from a third-party manufacturer.

Guidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).

Guidance on submitting the CPD for prescription medicines.

Guidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).

Guidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.

Guidance on when and how to provide Product Information to us.

Guidance to assist you with submitting acceptable applications for registration of over-the-counter (OTC) medicines.

Guidance on equivalence of herbal extracts in complementary medicines.

Guidance on the use of modified unprocessed herbal materials in complementary medicines

Guidance for manufacturers in the development of Technical Master Files (TMF) relevant to blood, blood components and haematopoietic progenitor cells.