If you're planning to bring a medicine to market in Australia, this is your starting point.
You need to understand how we regulate these products and your obligations at each stage. This includes choosing the right pathway, preparing evidence and meeting product standards.
Being well prepared helps ensure your product meets Australian requirements and avoids delays getting it to market.
Start by learning your responsibilities and planning each stage of your product’s lifecycle.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medicines. You may also have to meet obligations that apply to all products.
General information
Learn about how products are regulated.
-
PageAssessed listed medicines have low risk ingredients, but slightly higher risk indications (intended uses) than listed medicines.
-
PageOver-the-counter medicines (OTC) are not prescription medicines or complementary medicines.
-
PageInformation for sponsors on how the Therapeutic Goods Administration (TGA) defines and regulates prescription medicines.
-
PageThe ARGLM will help you navigate the regulatory requirements for listed and assessed listed medicines in Australia.
-
PageSearch for medicines allowed to be supplied in Australia, medicine ingredients and safety information.
-
-
PageIngredient requirements for non-prescription medicines
-
PageFind out the differences between food and medicine regulation and use our tool to know how your product is classified.
-
PageInformation about including listed complementary medicines on the ARTG
-
PageListed medicines can only contain low risk ingredients and use low level indications.
-
PageUnderstand the regulatory requirements and legislative framework to help you get started as a new sponsor.
-
PageLearn about your on-going responsibilities once your non-prescription medicine is on the Australian Register of Therapeutic Goods.
-
PageManufacturing information and standards for non-prescription medicines
-
PageResources for sponsors of listed medicines and registered complementary medicines
-
PageFind out how applications to register an OTC medicine are categorised into five levels based on risk.
-
GuidanceGuidance on the process and regulatory requirements to register prescription medicines.
-
-
PageOverview of the way we consider risks and benefits during the evaluation and post-market monitoring of products.
-
-
PageHow we regulate sunscreens and which sunscreens are excluded from therapeutic goods legislation.
-
-
PageInformation on how to legally supply a prescription medicine in Australia. This includes how to register the product in the Australian Register of Therapeutic Goods (ARTG) and guidance to understand the ongoing responsibilities.
-
GuidanceGuidance on our approved terminology for medicines.
-
PageAustralia has 3 types of complementary medicines available to consumers: listed, assessed listed and registered.
-
PageOverview of the application process for the different types of non-prescription medicines.
-
GuidanceGuidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
-
GuidanceGuidance on generic and originator medicines in the context of over-the-counter (OTC) non-prescription medicine applications.
-
GuidanceGuidance to help you understand the different types of complementary medicines.
-
GuidanceGuidance providing an overview of listed medicines and assessed listed medicines pathways and legislative requirements.
-
GuidanceThis guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.
-
GuidanceGuidance to help sponsors understand the legislative powers the TGA can use relating to market actions.
Definitions and classification
Understand how products are defined and classified.
-
-
-
-
PageMake sure your supplement, vitamin or complementary medicine is regulated as a non-prescription medicine
-
PageLearn how we regulate products known as complementary, alternative or traditional medicines.
-
GuidanceThis 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.
-
Decision treeUse this tool to determine if your product is a food or medicine.
-
Decision treeUse this decision tree to work out if the product you want to sell or supply in Australia is a therapeutic good.
-
Decision treeUse this decision tree to help you determine if your sports supplement is declared to be a therapeutic good.
-
PageHow the Therapeutic Goods Administration (TGA) classifies and regulates medicines.
-
PageNon-prescription medicines can be purchased without a prescription from a doctor or other health professional.
-
PageHow the TGA defines generic and biosimilar medicines and where to find information on generic and biosimilar prescription medicine registrations.
-
GuidanceGuidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
-
PageTherapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol.
Ingredients and scheduling
Get information about ingredient approvals and scheduling requirements.
-
FormsUse this form to propose a new approved herbal name or herbal substance name.
-
PageUnderstand how to construct a complete approved herbal name for use in applications and labels.
-
User guideA user guide for applicants using the TGA Business services (TBS) portal to complete an online application form for a new substance application.
-
-
PageInformation about types of ingredients, restrictions on use and why they are scheduled.
-
PageUnderstand what ingredient requirements apply to your therapeutic good.
-
FormsUpdated form used to notify us of proprietary ingredient mixtures for use in therapeutic goods.
-
-
Definition typeFind approved terminology for herbal ingredient plant preparations.
-
FormsThis form is to assist users of the Electronic Lodgement Facility (ELF) seeking preclearance for animal derived ingredients by detailing what the TGA is looking for and what supporting documents need to be provided.
-
PageInformation on proposing a new ingredient name to be included on the approved list.
-
PageA proprietary ingredient is a formulation, such as a flavour or fragrance, made with a mixture of ingredients
-
PageLinks to public notices on invitations for and public comment on scheduling proposals, scheduling decisions, applications and other consultations and reviews.
-
-
PageAn overview of the scheduling of medicines and chemicals in Australia.
-
PageLinks to and information on scheduling and the Poisons Standard including public notices, state and territory information, the scheduling advisory committees and proposed committee meeting dates and decision timeframes.
-
User guideHow to search TGA business services for approved ingredients and accepted TGA terminology.
-
PageCheck the requirements and restrictions associated with the use of each ingredient in your therapeutic good.
-
PageKnow which ingredients can be used in therapeutic sunscreens, which ones we've reviewed, the difference between mineral and chemical sunscreen ingredients and the safety of nanoparticles.
-
PageFind information on the Poisons Standard (the SUSMP), amending the Poisons Standard and Scheduling.
-
GuidanceGuidance on the application process and information required for a substance to be evaluated for use in listed medicines.
-
GuidanceGuidance for data requirements for microorganisms used as active ingredients in listed or registered complementary medicines. These are generally referred to as probiotics or postbiotics.
-
GuidanceGuidance on the use of modified unprocessed herbal materials in complementary medicines
-
GuidanceGuidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed medicines.
-
FormsPrescription medicines Minor Variation E-form now available
Legislation, Acts and Orders
Review the laws and legal orders that regulate therapeutic goods.
-
PageTherapeutic Goods (Excluded Goods) determinations and specifications.
-
PageFind information about legislation, acts and regulations, legislative instruments and other legislative information.
-
PageBlood, blood components and plasma derivatives are regulated under the Therapeutic Goods Act 1989.
-
PageLearn about Required Advisory Statements for Medicine Labels (RASML).
-
LegislationThe Poisons Standard classifies medicines and poisons into different Schedules, signifying the degree of risk and the control recommended to be exercised over their availability to the public. Sometimes referred to as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
-
PageThe Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories.
-
LegislationThis Instrument makes various amendments to the Therapeutic Goods Advertising Code.
-
LegislationThe Therapeutic Goods (Charges) Act 1989 regulates the fees associated with the registration and listing of therapeutic goods in Australia.
-
LegislationThis Specification provides what information must accompany an application to register complementary medicines on the Australian Register of Therapeutic Goods (ARTG).
-
LegislationThis Determination specifies what information must accompany applications to list complementary medicines on the Australian Register of Therapeutic Goods (ARTG).
-
LegislationThis Order clarifies whether specified goods or classes of goods are therapeutic goods according to the terms of the definition of 'therapeutic goods' in the Therapeutic Goods Act 1989.
-
LegislationThis Determination specifies goods that are excluded from regulation for the purposes of the Therapeutic Goods Act 1989.
-
PageGroup orders document the differences that result in goods being considered separate and distinct from other goods.
-
LegislationTo read the full text, visit the Federal Register of Legislation.
-
LegislationThis Specification facilitates the release of specified therapeutic goods information held by the TGA in the database known as the Database of Recalls, Product Alerts and Product Corrections (DRAC), relating to market actions involving therapeutic goods.
-
LegislationThis Instrument authorises the release of specified therapeutic goods information relating to medicine shortages and availability data either to a specified person, body or authority or to the public.
-
LegislationThis Specification specifies therapeutic goods information that may be released by the Secretary in relation to compliance reviews of listed medicines.
-
LegislationThis Determination sets out conditions for listing specified listed medicines on the Australian Register of Therapeutic Goods (ARTG).
-
LegislationThis Specification sets out the required advisory statements for specified non-prescription medicines, including over the counter and registered complementary medicines.
-
LegislationThis Specification facilitates the open publication of certain kinds of therapeutic goods information relating to ingredients of medicines and components of biologicals in the Australian Register of Therapeutic Goods (ARTG).
-
LegislationThese Rules authorise specified classes of health practitioners to supply specified therapeutic goods in certain circumstances, under the TGA's Special Access Scheme category C pathway.
-
LegislationThis Determination sets out the list of reportable medicines which forms the Medicines Watch List under s 30EJ(1) of the Therapeutic Goods Act 1989.
-
LegislationThe TGO 100 Order sets forth the minimum microbiological quality standards that therapeutic goods must meet.
-
LegislationThis Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of prescription and other related medicines.
-
LegislationThis Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of non-prescription medicines.
-
LegislationThis Therapeutic Goods Order constitutes a standard for child-resistant packaging for specified kinds of medicines.
-
LegislationThis Determination specifies the information that must accompany an application to register an over the counter medicine on the Australian Register of Therapeutic Goods (ARTG).
-
LegislationThis Determination sets out the list of permitted therapeutic claims (indications) which may be made in relation to medicines that are listed on the Australian Register of Therapeutic Goods (ARTG) under sections 26A, or 26AE, of the Therapeutic Goods Act 1989 (these are listed, and listed assessed medicines).
-
LegislationThis Determination sets out a list of ingredients which have been assessed or otherwise considered to be safe for use in medicines that are listed in the Australian Register of Therapeutic Goods (ARTG) (including assessed listed medicines), and associated requirements to be followed when using particular ingredients in such medicines.
-
LegislationThis Determination specifies the kind of information that must accompany an application for a recommendation by the Secretary that the Minister vary a section 26BB determination made under the Therapeutic Goods Act 1989.
-
LegislationThis Determination specifies the information that must accompany an application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
-
LegislationThis Specification facilitates the release of specified therapeutic goods information relating to prescription medicines to Therapeutic Guidelines Ltd (TGL) to facilitate the publication of specified information in the journal Australian Prescriber.
-
LegislationThis Specification facilitates the publication of specified therapeutic goods information relating to applications for the registration of prescription medicines in the Australian Register of Therapeutic Goods (ARTG).
-
LegislationThese regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia.
-
LegislationThe Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 outlines the quality standards for therapeutic goods such as tablets, capsules, and pills in Australia.
-
GuidanceGuidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
-
GuidanceGuidance to help sponsors understand the legislative powers the TGA can use relating to market actions.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
-
PageKnow the minimum acceptable approach to achieve validation of test procedures used for complementary medicines (products) and starting materials for use in complementary medicines.
-
GuidanceGuidance about evidence required to substantiate the quality of the product, for over-the-counter (OTC) medicine registration applications.
-
PageAssuring the safety and quality of non-prescription medicines
-
GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceGuidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).
-
PageComplying with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Manufacturing Practice (GMP).
-
GuidanceGuidance 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
-
User guideFinished product (medicine) analytical procedure validations for complementary medicines.
-
-
PageInformation on special considerations required for medicines for use in special populations.
-
GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
-
PageFind out what standards and requirements you must comply with to legally sell or supply your medicine in Australia.
-
FormsInformation on completing and submitting an OTC analytical validation summary form
-
PageFind the monographs available for over-the-counter (OTC) new medicine N2 applications.
-
PageExplains what our compositional guidelines are, how they are used and how to develop them by using compositional guideline templates.
-
GuidanceGuidance on the use of permitted indications in listed medicines.
-
PageSponsors can access a list of permitted therapeutic uses for medicines and find answers to commonly asked questions.
-
PagePharmacopoeias provide standards for pharmaceutical substances and medicinal products.
-
PageWe will be initiating targeted compliance reviews of selected listed medicines to evaluate compliance with the certifications made by sponsors at the time of listing a medicine on the ARTG
-
PageOverview of stability testing of listed complementary medicines for sponsors and manufacturers.
-
PageStandards and guidelines for prescription medicines
-
-
GuidanceGuidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).
-
GuidanceGuidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
-
GuidanceGuidance for sponsors on the information required to establish quality for listed medicines.
-
GuidanceTo use the N2 application pathway using OTC medicine monographs, you must ensure that your application meets the requirements for N2 applications.
-
Product types