Regulation of Complementary Therapies and Medicines

Links to information about the regulation and approval of the complementary and alternative therapies and medicines industry.

The Office of Complementary Medicines, which is part of the Therapeutic Goods Administration [Therapeutic Goods Administration], regulates and provides information on complementary medicines for Australians.

Updated May 2009

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45 Resources Found
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Title:   Composition of Ginkgo Biloba products
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA has recently conducted testing on twenty-two (22) batches of medicines, covering twenty (20) products, and a number of associated Ginkgo extract raw materials.
Date:   Oct 2009
Title:   Draft compositional guidelines
Publisher:   Australian Government Department of Health and Ageing
Description:   Complementary Medicine Compositional Guidelines are intended to provide clarity to the specific form or type of substances that the Therapeutic Goods Administration (TGA) approves for use in listed medicines.
Date:   Jul 2009
Title:   Complementary Medicines Evaluation Committee (CMEC)
Publisher:   Australian Government Department of Health and Ageing
Description:   The Complementary Medicines Evaluation Committee provides scientific and policy advice relating to controls on the supply and use of complementary medicines. The advice is provided with particular reference to safety, quality of products and where appropriate, efficacy relating to the claims made.
Date:   Jul 2009
Title:   European Union guidelines published as adopted in Australia
Publisher:   Australian Government Department of Health and Ageing
Description:   A list of European Union guidelines published as adopted in Australia
Date:   Jun 2009
Title:   Cost recovery impact statement - Annual review of fees and charges 2009-10 - Complementary medicines
Publisher:   Australian Government Department of Health and Ageing
Description:   The Therapeutic Goods Administration (TGA) is proposing to increase complementary medicines fees and charges by 14.3 per cent for 2009-2010.
Date:   Jun 2009
Title:   Product recalls
Publisher:   Australian Government Department of Health and Ageing
Description:   Links to consumer-level product recall notices issued by the Therapeutic Goods Administration.
Date:   Apr 2009
Title:   Regulation of complementary medicines
Publisher:   Australian Government Department of Health and Ageing
Description:   This page provides links to resources of relevance to complementary medicines.
Date:   Mar 2009
Title:   Controlling complementary medicine claims
Publisher:   Australian Prescriber
Description:   Despite the widespread and increasing use of complementary medicines, few of these products have been evaluated for efficacy or therapeutic equivalence.
Date:   Dec 2008
Title:   Forms for sponsors of complementary medicines
Publisher:   Australian Government Department of Health and Ageing
Description:   Links to forms for sponsors of complementary medicines
Date:   Nov 2008
Title:   Regulatory reforms proposed for complementary medicines
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA has recently completed stakeholder consultations on a number of regulatory reforms proposed for each therapeutic product sector.
Date:   Sep 2008
Title:   Required advisory statements for medicine labels
Publisher:   Australian Government Department of Health and Ageing
Description:   The Required Advisory Statements for Medicine Labels document was established to enable the transfer of all mandatory label advisory statements from the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) and the Therapeutic Goods Regulations to a new document, separate from but linked to TGO 69 - General requirements for labels for medicines.
Date:   Sep 2008
Title:   Guidance on product changes in ELF3
Publisher:   Australian Government Department of Health and Ageing
Description:   Following the inclusion of a product as a Listed medicine in the Australian Register of Therapeutic Goods (ARTG), sponsors may wish to change certain details previously advised to the TGA. This guidance document has been developed to provide assistance to sponsors so that they are able to determine if a change to their ARTG entry for a particular product is necessary and the regulatory impact that making certain changes to currently Listed products may have.
Date:   Aug 2008
Title:   Media statement: Commonwealth Government settlement with Pan Pharmaceuticals and its former Chief Executive
Publisher:   Australian Government Department of Health and Ageing
Description:   The Commonwealth Government today agreed to settle a civil claim which had been lodged in the Federal Court in Sydney by Pan Pharmaceuticals and its former Chief Executive.
Date:   Aug 2008
Title:   Substances that may be used in listed medicines in Australia
Publisher:   Australian Government Department of Health and Ageing
Description:   The following substances are eligible for use in medicines Listed on the Australian Register of Therapeutic Goods for supply in Australia. The list includes the approved role of the substance (ie. active, excipient, and/or component), and any restrictions and conditions that apply to the substance when used in Listed medicines.
Date:   Dec 2007
Title:   Compositional guidelines
Publisher:   Australian Government Department of Health and Ageing
Description:   Complementary Medicine Compositional Guidelines are intended to provide clarity to the specific form or type of substances that the Therapeutic Goods Administration (TGA) approves for use in listed medicines.
Date:   Jul 2007
Title:   The regulation of complementary medicines in Australia - An overview
Publisher:   Australian Government Department of Health and Ageing
Description:   In Australia, medicinal products containing herbs, vitamins, minerals, and nutritional supplements, homoeopathic medicines and certain aromatherapy products are referred to as 'complementary medicines'.
Date:   Apr 2007
Title:   Naming and regulatory approach for amino acids chelates, chelates and organic acid salts
Publisher:   Australian Government Department of Health and Ageing
Description:   The TGA seeks input to assist in the development of Compositional Monographs for chelated and organic acid salt ingredients for use in low risk medicines under the proposed Australia New Zealand Therapeutic Products regulatory scheme.
Date:   Mar 2007
Title:   Renaming of complementary medicine ingredient - Serenoa serrulata
Publisher:   Australian Government Department of Health and Ageing
Description:   The Therapeutic Goods Administration (TGA) Herbal Ingredient Names Committee (HINC) considered the naming of Serenoa serrulata at its twenty-eighth meeting.
Date:   Jan 2007
Title:   Implementation of the Government Response to the recommendations of the Expert Committee on Complementary Medicines in the Health System
Publisher:   Australian Government Department of Health and Ageing
Description:   An audit of progress with implementing the Government Response was conducted to gain a clear indication of progress to date, to identify key stakeholders, and to inform the development of an Implementation Plan for further action. Areas with responsibility for implementing the Government Response, including the TGA, other areas of the Department of Health and Ageing (DoHA), the Department of Education, Science and Training, and the Department of Industry, Tourism and Resources, were consulted.
Date:   Dec 2006
Title:   Arthritis: complementary therapies - myDr.com.au
Publisher:   myDr
Description:   Many people, including those troubled by arthritis, are turning to alternative ways of alleviating the pain associated with their condition.
Date:   Aug 2006
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