Australian regulatory guidelines for complementary medicines (ARGCM)
Version 8.0, April 2018
This guideline is currently under review.
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.
ARGCM Version 8 includes amendments to ARGCM Part C to incorporate legislative changes for substance evaluations.Other parts of the ARGCM will be amended in 2018 to reflect other legislative changes arising from the Government's complementary medicines 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 requesting evaluation of a substance for use in listed complementary medicines.
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