Therapeutic Goods Act 1989

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.

Guidance to help you understand requirements for disease information and advertising.

This guidance explains the new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances effective from 1 July 2024. It helps sponsors interpret the new classification rule, conformity assessment requirements and transition arrangements.

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

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 on the regulatory requirements for 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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.

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.

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

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

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

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

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

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

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

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

Guidance on our approved terminology for medicines.

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

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

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

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

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

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

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

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

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

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

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

Guidance for making an offer of enforceable undertaking to us.

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

Guidance on submitting the CPD for prescription medicines.

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

Guidance on complying with therapeutic goods advertising requirements.

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

Guidance on clinical performance requirements and risk mitigation strategies.

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

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

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

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

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

Guidance on medical device application processing timeframes.

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

Guidance for the requirements applicable to medical devices containing poisons.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Guidance on reporting adverse events for sponsors of medical devices.

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

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

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

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 advertising services that involve therapeutic goods.

Guidance on equivalence of herbal extracts in complementary medicines.

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

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.

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

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

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

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

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

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

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 on the transitional arrangements and obligations of sponsors and manufacturers.

Guidance on the transitional arrangements and obligations.

Guidance for sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) on transitional arrangements and obligations.

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

Guidance for sanctions and penalties for non-compliant advertising.

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

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

Guidance about when information released to the public about therapeutic goods is considered advertising.

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

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

Guidance to help sponsors understand the process of submitting a priority inclusion application.

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

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

Guidance for providing acceptable evidence to support indications and claims made about your listed medicine.

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

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

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.

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 what to do if the sponsor of a therapeutic good changes.

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

Information required to establish quality for listed medicines

Guidance on how the Poisons Standard is amended and the processes that underpin scheduling policy

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

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

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