Key regulatory guidance materials

The Therapeutic Goods Administration (TGA) has started a series of reforms to complementary medicines. These reforms seek to improve community confidence and understanding of the safety and quality of these medicines.

The key regulatory guidance materials that underpin the regulation of complementary medicines are being updated. These guidance materials relate to the regulatory framework for complementary medicines and assessment of evidence for complementary medicines (including weight loss products).

The updated materials are to be used by sponsors and are intended to improve community confidence in the safety and quality of these medicines.

Work to be conducted

The TGA will be working to deliver the following updated guidance materials:

• Australian Regulatory Guidelines for Complementary Medicines (ARGCM)
• Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants) ('the Evidence document').

Australian regulatory guidelines for complementary medicines

An update to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) to reflect the current legislative framework and processes will be published.

Evidence required to support indications for Listed medicines (excluding sunscreens and disinfectants)

The Evidence document is intended to replace the existing document 'Guidelines for Levels and Kinds of Evidence to Support Indications and Claims for Non-Registerable Medicines, including Complementary Medicines and other Listable Medicines'. In accordance with the intentions outlined in the Blueprint, the TGA will also seek to include the Evidence document in the regulations.

Timetable

See: Reform timeframe and progress

Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines

Components of this project will address the first recommendation of the Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines.

Contact

For further information about the complementary medicines regulatory feforms, contact the Complementary Medicines Branch.