Australian regulatory guidelines for complementary medicines (ARGCM)
Version 7.1, November 2017
The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia.
If you want to supply a complementary medicine in Australia, you may choose to employ a regulatory affairs consultant.
Version 7.0 of the ARGCM has been re-structured to increase accessibility. As part of the Government's complementary medicines reforms, TGA will be consulting on recommendations to support the use of new assessment and application pathways in 2017. We anticipate publishing new versions of the ARGCM to reflect these reforms.
- Complementary medicines: what they are
- Regulation of complementary medicines in Australia
- Complementary medicines exempt/excluded from certain regulatory requirements
- Complementary medicine practitioner medicines and exemptions
- Approved terminology for complementary medicines
- Types of complementary medicines
- Types of ingredients in listed and registered complementary medicines
- Complementary medicine presentation
- Advertising of complementary medicines
- Complementary medicines presented as composite packs or kits
- Complementary medicines for export
- Purchasing complementary medicines over the internet
- Complementary medicine interface issues
- Changes to complementary medicines
- TGA post market regulatory activity of complementary medicines
- Literature-based submissions for complementary medicines
- Mechanism for review of decisions made under the Act
New substance evaluation
This guidance is for applicants proposing new substances for use as an ingredient in listed medicines. You can submit an application for evaluation for suitability for use in listed medicines for:
- a new complementary medicine substance not currently a permitted ingredient; or
- a proposed new role or a change to a regulatory requirement of use for a permitted ingredient, for example: a proposal for an ingredient permitted for use as an excipient to be used as an active ingredient; or change to the permitted level of use; or change the permitted route of administration.
A request for evaluation of a new complementary medicine substance is considered under Regulation 16GA of the Therapeutic Goods Regulations 1990 (the Regulations). There is an associated fee.
The primary reason for the evaluation of a substance is to determine whether it is of appropriate quality and safety to be permitted for use as an ingredient in listed complementary medicines.
Once permitted for use in listed medicines, an ingredient may be used in a listed medicine by any sponsor.
- Route of evaluation for complementary medicines
- Substances eligible for evaluation for use in listed complementary medicines
- Application phases for a new complementary medicine substance
- Information required for an application for evaluation of a new complementary medicine substance
- Application format
- Administrative information
- General substance information
- Information required to demonstrate the quality of a new complementary medicine substance
- Information required to demonstrate safety of a new complementary medicine substance for use in listed medicines
- Compositional guidelines for complementary medicine substances
This guidance is provided for an 'applicant' - the person who submits an application for a new registered complementary medicine. You (the applicant) may or may not become the sponsor of the new registered medicine if it is approved.
This guidance applies to proposed registered medicines that are eligible for evaluation by the TGA's Complementary Medicines Branch (CMB) - refer to Route of evaluation for complementary medicines.
Where a medicine is/would be subject to Schedules 4, 8 and 9 of the Poisons Standard (SUSMP) it will be evaluated as a prescription medicine - refer to Australian Regulatory Guidelines for Prescription Medicines.
- Overview of registered complementary medicines
- Registration process for complementary medicines
- Getting started online
- Using the online RCM application form
- Completing the online application form for RCMs
- Once your application has been submitted
- Target evaluation timeframes
- Application categories for registered complementary medicines
- Cover letter for registered complementary medicines
- Data requirements matrix for RCMs
- CTD Module 1: registered complementary medicines
- Module 2: registered complementary medicines
- Quality information for a new registered complementary medicine
- Generic registered complementary medicines
- RCMs using active ingredients permitted in listed medicines
- Safety and efficacy information for a new registered complementary medicine
- Changes for registered complementary medicines
- Changes tables