Therapeutic Goods Regulations 1990
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 for instance specifying fees for applying for marketing approval for a therapeutic good or for a manufacturing licence, and setting out exemptions from the requirement for therapeutic goods other than medical devices to be included in the Australian Register of Therapeutic Goods.
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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.
Guidance referring to this legislation
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GuidanceGuidance providing an overview of listed medicines and listed assessed medicines pathways and legislative requirements.
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GuidanceGuidance on changing information in the ARTG for listed or assessed listed medicines.
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GuidanceGuidance on complying with therapeutic goods advertising requirements.
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GuidanceGuidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
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GuidanceThis 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).
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GuidanceGuidance about the Annual Charge Exemption scheme waiver process.
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GuidanceThis guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybin from 1 July 2023.
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GuidanceIf 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.
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GuidanceThis 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.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceClinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA's Good Clinical Practice (GCP) inspection program.
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GuidanceGuidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.
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GuidanceHow to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.
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GuidanceFrom 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.
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GuidanceThis guidance assists providers of IV drips to understand how to comply with the therapeutic goods advertising requirements in Australia.
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GuidanceThis guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.
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GuidanceThis guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
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GuidanceGuidance about the types of notifications and variations for biological medicines.
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
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GuidanceThis guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.
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GuidanceThis Guidance explains part 8 of the Code, which outlines rules for making restricted representations when advertising therapeutic goods.
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GuidanceGuidance on using reports from COBs and submission requirements for evaluation of these applications.
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GuidanceGuidance explaining how the Comparable Overseas Bodies report-based process is associated with shortened evaluation timeframes for applications.
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GuidanceGuidance for biological sponsors on the eligibility criteria and supporting documents required for priority determination applications
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GuidanceGuidance for importation, supply and wholesale requirements for medicinal cannabis.
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GuidanceGuidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
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GuidanceRelease 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.
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GuidanceGuidance to help determine whether products are separate and distinct biologicals that will need to be included as separate ARTG entries.
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GuidanceGuidance 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.
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GuidanceThis 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.
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GuidanceGuidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.
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GuidanceGuidance on the process and regulatory requirements to register prescription medicines.
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GuidanceGuidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.
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Applying for a Class 1 biological to be added in the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for preparing and submitting an application for inclusion of a Class 1 biological on the ARTG. -
GuidanceGuidance on how exempt disinfectants are defined and meeting the regulatory requirements for their manufacture, supply and advertising.
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GuidanceGuidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.
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GuidanceThis guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.
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GuidanceThis guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes.
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GuidanceGuidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
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Accessing unapproved biologicals that are not on the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for people who want to access biologicals that are not included on the Australian Register of Therapeutic Goods (ARTG). -
GuidanceAustralian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.
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GuidanceGuidance on how to request early scientific advice on a biowaiver justification.
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GuidanceGuidance for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products.
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GuidanceGuidance for sponsors of faecal microbiota transplant (FMT) products, which are regulated as biologicals.
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GuidanceGuidance for new sponsors on how to supply, import, and export disinfectant products.
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GuidanceGuidance for sponsors on the eligibility criteria for reduced application and evaluation fees for major variation applications for prescription medicines.
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GuidanceThis guidance explains requirements for registering a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance on the evaluation process and information required for new registered complementary medicines.
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GuidanceGuidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
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GuidanceInformation required to establish quality for listed medicines
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GuidanceGuidance on our approved terminology for medicines.
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GuidanceThis guidance provides information about preparing Consumer Medicine Information (CMI) documents that comply with current regulations.
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GuidanceGuidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
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GuidanceGuidance on bioavailability and/or bioequivalence aspects of prescription medicines including information on biowaivers.
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Applying for new over-the-counter inhalation or nasal spray medicines or changing existing medicines
GuidanceGuidance about application pathways and data requirements for new generic medicines, and variations to existing medicines. -
GuidanceGuidance for making an offer of enforceable undertaking to us.
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GuidanceGuidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.
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GuidanceGuidance explaining how the method of preparation influences classification and whether autologous HCTs are eligible for exemptions.
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GuidanceGuidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.
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GuidanceGuidance for sponsors on how and when to use a boxed warning in PI or a CMI.
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GuidanceGuidance for sunscreen manufacturers who must comply with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-13).
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GuidanceGuidance on applying for a provisional determination, which is the first step of the provisional approval pathway.
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GuidanceGuidance for sponsors about how to apply for orphan drug designation for a prescription medicine.
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GuidanceGuidance about the process of applying for a priority determination, which is the first step of the priority review registration pathway.
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GuidanceGuidance to assist sponsors understand the process for submitting a priority registration application.
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GuidanceGuidance on provisional registration process for prescription medicines with provisional determination.
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GuidanceGuidance to explain how the intended use of a biological product influences its classification and exemptions.
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GuidanceGuidance to help work out if your autologous HCT product is exempt from some aspects of our regulation.
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GuidanceGuidance 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).
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GuidanceGuidance to help you understand the different types of complementary medicines.
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GuidanceGuidance on how we make use of assessments from comparable overseas regulators (CORs).
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GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).
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GuidanceAssists in the interpretation of the PIC/S GMP requirements when manufacturing compounded medicines
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GuidanceGuidance on generic and originator medicines in the context of over-the-counter (OTC) non-prescription medicine applications.
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GuidanceGuidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.
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GuidanceGuidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines
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GuidanceGuidance on declaring and managing conflicts of interest and confidentiality obligations for TGA advisory committee members.
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GuidanceGuidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
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GuidanceGuidance on when and how to provide Product Information to us.
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GuidanceGuidance on equivalence of herbal extracts in complementary medicines.
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GuidanceGuidance on the use of modified unprocessed herbal materials in complementary medicines
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GuidanceGuidance for manufacturers in the development of Technical Master Files (TMF) relevant to blood, blood components and haematopoietic progenitor cells.