Australian Regulatory Guidelines for Listed Medicines (ARGLM)
The ARGLM will help you navigate the regulatory requirements for listed medicines in Australia. This includes requirements for applications, safety, ingredients, labelling and advertising.
Last updated
Regulation basics
General information on how we regulate listed medicines and sunscreens in Australia.
-
GuidanceGuidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.
-
GuidanceGuidance providing an overview of listed medicines and assessed listed medicines pathways and legislative requirements.
-
GuidanceGuidance on the use of permitted indications in listed medicines.
-
GuidanceGuidance explaining the post-market surveillance of listed medicines and how we undertake compliance reviews.
-
Definition typeView terms and acronyms commonly used in Australian therapeutic goods regulation, and their definitions. This list is intended for general informational purposes and is not exhaustive.
Sunscreens
-
GuidanceThis guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.
Applications and submissions
-
User guideA guide for using the TGA Business services (TBS) portal for listed and assessed listed medicine applications.
-
User guideA user guide for applicants using the TGA Business services (TBS) portal to complete an online application form for a new substance application.
-
GuidanceGuidance on what information to include in an application to vary the Therapeutic Goods (Permissible Ingredients) Determination.
-
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 regulatory requirements for assessed listed medicines.
-
GuidanceGuidance on using literature based submissions for applications for listed, assessed listed and registered complementary medicines.
-
PageFind information about using reports from Comparable Overseas Bodies for applications for listed, assessed listed and registered complementary medicines.
-
GuidanceGuidance on changing information in the ARTG for listed or assessed listed medicines.
-
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
Safety and quality
Information on quality and safety requirements and international guidelines we have adopted.
-
GuidanceGuidance for sponsors on the information required to establish quality for listed medicines.
-
PageOverview of stability testing of listed complementary medicines for sponsors and manufacturers.
-
PageKnow the minimum acceptable approach to achieve validation of test procedures used for complementary medicines (products) and starting materials for use in complementary medicines.
-
PageInformation for sponsors and manufacturers on assessing the risk of potential nitrosamine contamination in listed medicines.
-
Resource typeAccess a list of international guidelines that have been adopted in Australia before manufacturing and supplying your medicine or biological.
-
International scientific guidelines adopted in AustraliaAccess European Union guidelines adopted in Australia that are related to complementary medicines.
-
PageExplains what our compositional guidelines are, how they are used and how to develop them by using compositional guideline templates.
-
Resource typeAccess a list of ingredients permitted for use in listed medicines that have a TGA compositional guideline.
Efficacy
-
GuidanceGuidance for holding acceptable evidence to support indications and claims made about your listed medicine.
-
GuidanceGuidance on the regulatory requirements for assessed listed medicines.
Ingredients and substances
-
GuidanceGuidance on our approved terminology for medicines.
-
PageAll ingredients used in therapeutic goods require an Australian Approved Name.
-
-
PageInformation on colourings in medicines for topical and oral use.
Manufacturing
-
PageLinks to information on therapeutic goods manufacturing licenses and overseas Good Manufacturing Practice (GMP) clearance and certification.
-
PageComplying with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Manufacturing Practice (GMP).
Labelling and advertising
-
GuidanceProvides guidance on the regulatory requirements for labels and other medicine presentation.
-
GuidanceGuidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
-
PageThe Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) outlines requirements when advertising to the general public.
Legislation
-
LegislationThe Therapeutic Goods Act 1989 provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.
-
LegislationThese regulations provide requirements relating to the manufacturing, supply and advertising of therapeutic goods in Australia.
-
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 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 Instrument contains the Therapeutic Goods Advertising Code. The Code specifies a range of requirements to protect the Australian public from the personal and public health risks associated with unethical, inaccurate or misleading advertising practices relating to the advertising of therapeutic goods.
-
LegislationThis Therapeutic Goods Order constitutes a standard for child-resistant packaging for specified kinds of medicines.
-
LegislationThe TGO 100 Order sets forth the minimum microbiological quality standards that therapeutic goods must meet.
-
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.
-
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 Determination sets legally enforceable standards to ensure therapeutic goods in Australia are manufactured safely, consistently, and to high quality.
More information about legislation
-
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.
-
-
PageGroup orders document the differences that result in goods being considered separate and distinct from other goods.
-
PageTherapeutic Goods (Excluded Goods) determinations and specifications.
-
-
GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
Product types
Page history
Updated to include a link to the Therapeutic Goods (Permissible Indications) Determination under the Legislation section.
Updated to include a link to new guidance titled Understanding nitrosamine risk in listed medicines.
Updated to include a link to the Therapeutic Goods (Permissible Indications) Determination under the Legislation section.
Updated to include a link to new guidance titled Understanding nitrosamine risk in listed medicines.