The information in this section includes regulatory decisions and notices about the regulation of complementary medicines. This information is over 5 years old, revoked or superseded.

2020 2019 2018 2017 2016 2015 2014 2013 2012 2011 2010 2007 2005 2004 2001

2020

• Transition for permitted indications for listed medicines ends 5 March 2021
  13 November 2020: On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under section 26A of the Therapeutic Goods Act 1989.
• Update on proposed clarification that certain sports supplements are therapeutic goods
  17 March 2020: Following the public consultation held in October-December 2019, an update to the proposed clarification that certain sports supplements are therapeutic goods has been published.

2019

• Changes to permissible indications for listed medicines
  12 September 2019: Outlines changes that were made to the Therapeutic Goods (Permissible Indications) Determination No. 1 of 2018 in February 2019

2018

• List of evaluated registered complementary medicines
  11 September 2018: List of registered complementary medicines on the ARTG that have been evaluated by the TGA for safety, quality and efficacy

2017

• Submissions received and TGA response: Reforms to the regulatory framework for complementary medicines
  11 July 2017: Consultation outcomes published
• Review and appeal rights for ingredient applicants
  3 July 2017: On 1 July 2017 the Therapeutic Goods Act 1989 was amended to provide for review and appeal rights in relation to the assessment of new ingredients for use in listed complementary medicines.
• Catalogue of permitted ingredients for use in listed medicine
  4 April 2017: The TGA has published a searchable online catalogue of ingredients approved for use in listed medicines
• Permissible Ingredients Determination: Forecast of updates
  4 April 2017: Anticipated timeframe for updates to the Permissible Ingredients Determination in 2017

2016

• Permissible Ingredients Determination: Frequently asked questions
  6 January 2016 : On 1 January 2016, a new legislative instrument under section 26BB of the Therapeutic Goods Act 1989, the Therapeutic Goods (Permissible Ingredients) Determination was introduced

2015

• Marketing complementary medicines with soft gel capsules for children
  29 June 2015 : Soft gel capsules may pose a choking hazard for children, especially those aged under five years
• New ingredient names available for metal amino acid chelates
  6 March 2015 : Specific Australian Approved Names (AANs) for metal amino acid chelates have been made available for use in the Electronic Listing Facility (ELF)

2014

• Complementary medicines reforms
  25 June 2014: Therapeutic Goods Administration (TGA) has undertaken a series of reforms to complementary medicines to improve community confidence in the safety and quality of these medicines.

2013

• Compositional guideline: Deer velvet antler powder - amendment
  28 March 2013: The acceptance criterion for 'Ash' has been amended to 15.0 - 47.6% (dried basis)

2012

• Indications for Listed medicines that refer to biomarkers
  29 June 2012: Listed medicines are restricted to indications and claims relating to health maintenance, health enhancement or non-serious, self-limiting conditions
• Deactivation of superseded herbal ingredient names
  7 June 2012 : On 30 May 2012 the TGA completed changes to the ARTG entries of medicines affected by the update to herbal ingredient names and deactivation of superseded herbal ingredient names
• Information about weight loss product 'Undoit'
  23 May 2012: The sponsor has cancelled the product's listing on the Australian Register of Therapeutic Goods and the TGA's review of the product is closed

2011

• Cancellation of Sensaslim Solution from the ARTG
  24 November 2011 : The TGA has cancelled the product's listing on the Australian Register of Therapeutic Goods

2010

• New process for lodgement of applications for new registered complementary medicines
  3 December 2010: The registered over-the-counter medicines online application system accepts applications for new registered complementary medicines

2007

• Serenoa serrulata (renaming)
  16 January 2007: The TGA Herbal Ingredient Names Committee considered the naming of Serenoa serrulata at its 28th meeting.

2005

• Hydroxycitrate complex (update)
  31 May 2005 : The compositional guideline for hydroxycitric acid and hydroxycitrates derived from Garcinia quaesita has been revised by the TGA.
• Codex
  10 May 2005: The proposed Codex Guidelines on Vitamin and Mineral Supplements will NOT apply in Australia and will have NO IMPACT on the way these types of products are regulated in Australia

2004

• Folic acid preparations dissolution requirements
  29 March 2004: In 2001, the TGA was advised of reports from the United States that some folic acid-containing tablets failed to release folic acid when analysed by conventional dissolution tests.
• Colloidal silver & related products
  26 March 2004: Colloidal products which make therapeutic claims are classified as therapeutic goods

2001

• SAMe ((S)-S-adenosylmethionine)
  17 July 2001: Subregulation 9(2) gazette notice relating to the substances (S)-S-adenosylmethionine and ademetionine (also known as 'SAMe')