Standards, guidelines & publications (complementary medicines)
- Australian regulatory guidelines for complementary medicines (ARGCM)
The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) is reflects the current Australian requirements for the regulation of complementary medicines
- Analytical procedure validation for complementary medicines
These guidance documents describe the minimum approach considered to be acceptable to achieve validation of the test procedures used for complementary medicines (products) and starting materials for use in complementary medicines
- Compositional guidelines
Complementary medicine compositional guidelines are intended to provide clarity to the specific form or type of substances that the TGA approves for use in listed medicines
- Evidence guidelines
These guidelines provide information for sponsors and applicants on the type of evidence that is required to support indications for listed complementary medicines and to understand the regulatory obligations in relation to holding evidence to support indications for your medicine.
- European Union guidelines used by the Office of Complementary Medicines
List of European Union guidelines adopted in Australia used by the Office of Complementary Medicines
- Guidance for new registered complementary medicine applications
This guideline explains the process for electronic submission of an application for a new registered complementary medicine using the TGA eBusiness Over The Counter medicine portal.
- Colourings used in medicines for topical and oral use
Lists the colourings that may be used in topical and oral medicines, the regulatory and data requirements for new colourings
- Herbal materials & extracts
Guidelines on herbal materials and extracts
- Ingredients/excipients in Listed medicines
Links to information about the regulation of ingredients and excipients in Listed medicines
- Information sources that could assist regulators with market authorisation of complementary/ herbal medicine ingredients
This document serves as a resource on the regulatory framework of herbal and other complementary medicine ingredients in a number of regulatory agencies.
- Section 7 declarations - is it a therapeutic good?
Section 7 declarations are made under the Act to provide greater clarity in determining whether a product is a food or a therapeutic good
- Stability testing of Listed complementary medicines
Questions and answers on stability testing of complementary medicines to provide additional guidance to sponsors and manufacturers
- Substances that may be used in Listed medicines in Australia
These substances are eligible for use in medicines Listed on the Australian Register of Therapeutic Goods for supply in Australia
- TGA approved terminology for medicines
Lists of Australian Approved terminology that ensure accuracy and consistency in the information compiled in the ARTG. For medicines, the lists cover substances (active ingredients and excipients), containers, dosage forms, routes of administration and units of expression and proportion.
- Listed medicines application and submission user guide
Training guide for the Electronic Listing Facility for listed and soley for export medicines. It outlines the system and provides instructions for producing and submitting applications
- Guidance on product changes in ELF3
Following the inclusion of a product as a Listed medicine in the Australian Register of Therapeutic Goods (ARTG), sponsors may wish to change certain details previously advised to the TGA.
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Content last updated:
Wednesday, 27 May 2015