On this page: Guidance applicable to all listed medicines and registered complementary medicines | Guidance specific to listed medicines | Guidance specific to registered complementary medicines

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
• Analytical procedure validation for complementary medicines
  Guidance on the minimum approach to achieve validation of the test procedures and starting materials
• TGA approved terminology for medicines
  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

• Equivalence of herbal extracts in complementary medicines
• Identification of herbal materials and extracts
• Use of modified unprocessed herbal materials in complementary medicines

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
• Compositional guidelines
  List of current compositional guidelines
• Applications for new substances in listed medicines
  (Formerly ARGCM V8.0 Part C)
  Guidance on the process for a substance to be evaluated for use as a new ingredient in listed medicines.
• Information required in an evaluation of a substance for use in listed medicines: guidance for sponsors
• 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