NICM Health Research Institute (NICM HRI) established in 2007, support by the Commonwealth and NSW Government is an independent, national agency which provides strategic leadership in integrative clinical research and policy for the health of all Australians. It plays a key role in ensuring Australians have access to reliable evidence on complementary medicines and treatment in wide use. In 2013, NICM HRI known as an ERA 5 institute incorporating with the Centre for Complementary Research (CompleMED) is now recognised internationally for world-class research in traditional Chinese Medicine. NICM also collaborates with national and international bodies including the World Health Organisation, the Therapeutic Goods Administration’s Advisory Committee on Complementary Medicines (ACCM) and the National Health and Medical Research Council in order to improve integrative care. NICM undertakes research on policy issues relating to complementary medicine in Australia, such as safety, usage, industry regulation and clinical practice standards. This research underpins NICM’s advocacy work.
Contact Details
Therapeutic Goods Administration
TGA, PO Box 100Woden ACT 2606
Australia
Tel.: 1800 020 653 (free call within Australia) +61 2 6289 4124 (overseas call) 02 6289 4124 (for mobiles that do not allow 1800 calls)
Fax: 02 6203 1605
Email: [email protected]
Website:http://www.tga.gov.au
Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Tel.: 02 6289 1555 (switchboard)1800 020 103 (free call)
Website:http://www.health.gov.au
National Institute for Complementary Medicine (NICM)
NICM Health Research Institute
Western Sdyney University
Locked Bag 1797
Penrith NSW 2751Australia
Tel.: +61 2 96854700
Fax: +61 2 9685 4760Email: [email protected]
Website: https://www.westernsydney.edu.au/
Laws and Regulations
All dietary supplements including botanicals are regulated by the Australian Government Department of Health, Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act of 1989. This Act covers almost all regulatory aspects of all vitamins, minerals, herbs and nutritional supplements, but in some instances, certain products may be subject to separate regulatory guidance by State and Territorial authority. All products listed above are considered to be complementary medicines under the Act. This includes Traditional Chinese Medicine, Ayurvedic Medicine, Indigenous Medicines, Homeopathy and Aromatherapy.
Australia has developed a two-tiered approach to the regulation of complementary medicine which falls under therapeutic goods. Claims on nutritional products making reference to any disease otherwise must be include in the Australian Register of Therapeutic Goods (ARTG) before they can be legally marketed in Australia.
The British pharmacopoeia is used and considered legally binding. GMP’s are the same as those used for conventional drugs. TGA in conjunction with the Australian Self Medication Industry (ASMI) and the Complementary Healthcare Council of Australia (CHC) has established industry guidelines to assist manufacturers, marketers, retailers and importers in complying with the various regulations.
A post-marketing surveillance program tracking adverse events has been in place since the early 1970’s.
Regulations have been in place since the implementation of the Therapeutic Goods Act.
Contact
Therapeutic Goods Administration
TGA, PO Box 100
Woden ACT 2606
Australia
Tel.: 1800 020 653 (free call within Australia)+61 2 6289 4124 (overseas call) 02 6289 4124 (for mobiles that do not allow 1800 calls)
Fax: 02 6203 1605
Email: [email protected]
Website:http://www.tga.gov.au
Standards and Guidelines
Australian code of Good Manufacturing Practice (GMP) for medicinal products includes herbal medicinal products. Guide to interpretation of the Australian Code of GMP for Medicinal Products is also applicable to the manufacturing process of complementary medicines.
The Australian regulatory guidelines for listed medicines and registered complementary medicines are intended to provide guidance on the requirements for the Registration of complementary medicines.
Australian Government Department of Health regulates the Therapeutic Goods Act 1989, which is the primary legislation that governs the area of prescription medicine, medical devices and complementary medicines since 15 February 1991. The objective of the act is to provide good availability of therapeutic goods to the consumers.
The Therapeutics Goods Advertising Code which took action since 2007 aims at promoting the quality use of the products and making sure that the labelling of the products do not deceive the customers. It regulates the marketing and the advertising of the therapeutic goods in order to protect the safe interest of the consumers.
Therapeutic goods must be registered with the Australian Register of Therapeutic Goods (ARTG) before they can be legally sold in Australia.
In Australia, clinical trials must follow the Ethical Principles of the Declaration of Helsinki and the international Good Clinical Practice guidelines. Before a clinical trial is performed, it needs to be approved by the independent ethics committees that operate according to the guidelines issued by the National Health and Medical Research Council (NHMRC Guidelines).
Australia is an OECD member country which adheres to the OECD principles and guidelines.
Contact National Health and Medical Research Council (NHMRC)
Street Address:
16 Marcus Clarke Street
Canberra ACT 2601
Postal Address:
GPO Box 1421
Canberra ACT 2601
Tel.: 1300 064 672 (within Australia)
or +61 2 6217 9000 (overseas call)
Email: [email protected]
Website: https://www.nhmrc.gov.au/
Therapeutic Goods Administration
TGA, PO Box 100
Woden ACT 2606
Australia
Tel.: 1800 020 653 (free call within Australia) +61 2 6289 4124 (overseas call)02 6289 4124 (for mobiles that do not allow 1800 calls)
Fax: 02 6203 1605
Email: [email protected]
Website:http://www.tga.gov.au
