Australia

The Australian National Medicines Policy in year 2000 aims to improve positive health outcomes for all Australians through their access to and wise use of medicines which include both prescriptive and non-prescriptive medicines, including complementary healthcare products. In R&D field, by the year 2003, following the recommendations of the Expert Committee on Complementary Medicines in the Australian Health System, the National Institute of Complementary Medicine (NICM) was established which an independent, national agency is providing strategic leadership in complementary medicine research and policy for the health of all Australians. In line with the aim of improving the health of Australians too, the Australian government will introduce a comprehensive package of reforms for Australia’s Therapeutic Goods Administration (TGA) to ensure the regulation of medicines and medical devices is more effective and transparent which has special interest in the effectiveness of complementary medicines, their promotion and the adequate evaluation of some high risk medical devices.

Contact Details

Therapeutic Goods Administration 
TGA, PO Box 100, Woden ACT 2606, Australia                                                                                                                                        
Tel: 1800 020 653
Website:http://www.tga.gov.au      
                                                                                                                                                                         
Dept of Health & Ageing,
Central Office,
GPO Box 9848,
Canberra ACT 2601, Australia
Switchboard: 02 6289 1555
Freecall: 1800 020 103
Website:http://www.health.gov.au   
                                                                                                                                                                             
The Administrative Officer
National Institute of Complementary Medicine (NICM)
UWS - Bldg 3 Campbelltown Campus
Locked Bag 1797
South Penrith DC 1797
Tel.: (02) 4620 3284
Fax: (02) 4620 3722

 

Laws and Regulations

All dietary supplements including botanicals are regulated by the Department of Health and Aging, Therapeutic Goods Administration 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.

Claims on nutritional products making reference to any disease are prohibited though, currently there is legislation in process that will regulate such claims.

The British pharmacopoeia is used and considered legally binding. GMP's are the same as those used for conventional drugs. The Therapeutic Goods Administration (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. Australia has developed a two tiered approach to the regulation of complementary medicine which falls under therapeutic goods.

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 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 Complementary Medicines (ARGCM) is intended to provide guidance on the requirements for the Registration of complementary medicines.

The Ministry of Health and Ageing 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).

The Australian government will introduce a comprehensive package of reforms for Australia’s Therapeutic Goods Administration (TGA) in ensuring the effectiveness and transparent regulation of medicines and medical devices which has special interest in complementary medicines, their promotion and the adequate evaluation of some high risk medical devices.

Australia is an OECD member country which adheres to the OECD principles and guidelines.

Contact 

National Health and Medical Research Council (NHMRC)
Street Address: Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Postal Address: National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Telephone: 13 000 NHMRC (13 000 64672) 
or +61 2 6217 9000
Fax: +61 2 6217 9100
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Address: TGA, PO Box 100, Woden ACT 2606, Australia
phone no/fax: -
Telephone: 1800 020 653
email: This email address is being protected from spambots. You need JavaScript enabled to view it.
website: http://www.tga.gov.au/