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The Australian regulatory guidelines for listed medicines and registered complementary medicines (published May 2020) replaces ARGCM V8.0. The new version reflects recent reforms to the regulatory framework and presents guidance in separate documents to facilitate timely updates. This is an interim step towards a new landing page, which will be modelled on the Australian Guidelines for Prescription Medicines.
We welcome your feedback on the revised guidance, using the feedback form on this page.
Guidance applicable to all listed medicines and registered complementary medicines
- Overview of the regulation of listed medicines and registered complementary medicines
(Formerly ARGCM V.8 Part A)
General guidance on the regulation of listed medicines and registered complementary medicines in Australia - Literature-based submissions for listed medicines and registered complementary medicines (Formerly included in ARGCM V.8 Part A)
Guidance on using literature based submissions for applications for listed medicine and registered complementary medicines - Comparable overseas bodies (COBs) for complementary medicines
Guidance on using assessments from comparable overseas bodies in evaluations for complementary medicines and listed OTC medicines - Requirements for microorganism characterisation in listed medicines and registered complementary medicines
Data requirements for applications relating to microorganisms used as active ingredients in listed medicines or registered complementary medicines. These are generally referred to as probiotics or postbiotics. - Analytical procedure validation for complementary medicines
Guidance on the minimum approach to achieve validation of the test procedures and starting materials - Naming ingredients
Approved terminology information compiled in the ARTG - Colourings used in medicines for topical and oral use
Regulatory and data requirements for new colourings
Guidelines on herbal materials & extracts
International guidelines adopted by the TGA
- EU and ICH guidelines adopted in Australia
- European Union guidelines used by the Office of Complementary Medicines
Guidance specific to sunscreen therapeutic products
- Sunscreens regulation basics
General information about how sunscreens are regulated in Australia - Standards, guidelines & publications (sunscreens)
Standards, guidelines and publications about the regulation of sunscreens
Guidance specific to listed medicines
Guidance for both listed and assessed listed medicines
- General guidance for listed medicines
(Formerly ARGCM V 8.0 Part B)
Guidance on the regulatory framework for ‘lower risk’ listed medicines. - Quality for listed medicines
(Formerly included in ARGCM V8.0 Part B)
Provides guidance on the information required to establish quality for listed medicines - Listed medicine presentation and labels
(Formerly included in ARGCM V8.0 Part A)
Provides guidance on the regulatory requirements for labels and other medicine presentation - Stability testing of listed complementary medicines
Information on stability testing of complementary medicines - Listed and assessed listed medicines: Application and submission user guide
User guide for the Electronic Listing Facility for listed and assessed listed medicine - Mandatory requirements for an application to vary the Permissible Ingredients Determination
- Application requirements for new substance for use in listed medicines
Guidance on the application process and information required for a substance to be evaluated for use as a new ingredient in listed medicines - Overview of compositional guidelines and templates
Guidance about compositional guidelines and templates to help develop them for a new substance application List of compositional guidelines
List of recently added compositional guidelines- Evaluation of substances for use in listed medicines: application user guide
Guidance for a using the online application form to apply for the TGA to evaluate: a new substance; or change in requirements of an existing ingredient permitted for use in listed medicines - Changing a listed or assessed listed medicine: application levels and change tables
(Replaces previous publication: Guidance on product changes in ELF3)
Guidance on changing information in the ARTG for listed or assessed listed medicines - Listed medicine compliance reviews
Information on the listed compliance review process and access to other resources related to listed compliance reviews.
Guidance specific to AUST L listed medicines
- Evidence guidelines
Guidance on the evidence required to support indications for listed complementary medicines. - Permitted indications for listed medicines guidance
Information on what permitted indications are, how to use them and how to apply for inclusion of new indications on the permitted indications list.
Guidance specific to AUST L(A) assessed listed medicines
- Assessed listed medicines evidence guidelines
Guidance on the regulatory requirements for listed assed medicine - Guidelines for using the TGA assessed claim on medicine labels
Guidance on how the TGA assessed claim can be used on medicine labels and in other advertising
Guidance specific to registered complementary medicines
- Applications for registered complementary medicines
(Formerly ARGCM V 8.0 Part D)
Guidance on the evaluation process for new registered complementary medicines. - Mandatory requirements for an effective registered complementary medicine application
- CTD Module 1: Administrative information for registered complementary medicines - Guidance for applicants
(Formerly included in ARGCM V 8.0 Part D)
Guidance on information required in applications for registered complementary medicines - CTD modules 2, 3, 4 and 5 for registered complementary medicine applications - Guidance for applicants
(Formerly included in ARGCM V 8.0 Part D)
Guidance on information required in applications for registered complementary medicines - Application and submission user guide: Registered complementary (RCM) and OTC medicines applications
User guide for submitting applications for registered complementary and OTC medicines - Guidelines for using the TGA assessed claim on medicine labels
Guidance on how the TGA assessed claim can be used on medicine labels and in other advertising - Changing a registered complementary medicine RCM: application levels and changes tables
(Formerly included in ARGCM V 8.0 Part D)
Guidance on changing information in the ARTG for registered complementary medicines - Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected