The TGA publishes a number of newsletters and articles.

Articles

2019

• Therapeutic Goods Amendment (Declared Goods) Order 2019: Folate substances
  7 November 2019: Certain folate substances presented as foods or dietary management products have been declared therapeutic goods
• Brexit - Implications for therapeutic goods in Australia
  1 November 2019: TGA will implement transitional arrangements for Brexit to ensure minimal interruption in the supply of therapeutic goods in Australia
• New Therapeutic Goods (Declared Goods) Order 2019
  28 October 2019: The Order consolidates within a single instrument all declarations formerly made under section 7 of the Act
• Tabling of Report on the Review into the 2016 Medicinal Cannabis amendments to the Narcotic Drugs Act 1967
  5 September 2019: Professor McMillan's Final Report on the Review of the Act was tabled in Parliament on Thursday 5 September 2019
• The TGA launches new tool to help sponsors find information on registering prescription medicines
  3 September 2019: This tool allows users to find guidance documents, forms and other resources relating to registering prescription medicines
• Consumer fact sheet: recall of Allergan Biocell breast implants
  3 September 2019: A fact sheet to support consumers following a recall of Allergan Biocell breast implants has been published
• An Action Plan for Medical Devices
  4 April 2019: An 'Action Plan for Medical Devices' was released on 4 April 2019. The Action Plan will further improve Australia's medical device regulatory system and place patient safety first.

2018

• 2018 survey results: TGA trusted but not yet a household name
  20 December 2018: 2018 TGA stakeholder survey reports available
• Therapeutic Goods (Microbiological Standards for Medicines)(TGO 100) Order 2018
  12 December 2018: TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98
• Updates to the Database of TGA laboratory testing results
  5 December 2018: New release of results published
• Comparable Overseas Reports (COR-A) pathway - First registration decision
  2 November 2018: Cabozantinib (CABOMETYX) is the first medicine to be registered via the new COR-A pathway
• Adverse event reporting made easier for GPs - Template forms now available
  18 October 2018: These templates can be installed in GP's desktop software to make it easier and more convenient for them to report ADRs to the TGA
• TGO 98 Microbiological Standards for Medicines (2018)
  2 October 2018: TGO 98 has been registered on the Federal Register of Legislation. It commences on 1 October 2018, succeeding TGO 77
• Research: Software as a Medical Device and Cyber Security for Medical Devices
  7 August 2018: Opportunity to participate in CSIRO research to inform new Australian medical device industry guidance
• Provisional approval pathway - first determination decision
  16 April 2018: First medicine to be granted a provisional approval determination
• Adverse events ('side effects') reporting survey
  5 April 2018: Undertaking this short survey will help us improve the way we collect and use adverse event reports to safeguard all Australians
• Changes to the therapeutic goods advertising framework
  13 March 2018: Changes to the advertising regulatory framework will commence March 2018
• Growing complacency with cosmetic injections could have serious consequences
  5 March 2018: As these non-surgical cosmetic procedures become more common, there is concern over growing complacency regarding the associated risks
• Priority review pathway - First registration decision
  6 February 2018: First medicine registered via the Priority review pathway
• Implementation of the NEW Uniform Recall Procedure for Therapeutic Goods (URPTG)
  12 January 2018: New URPTG effective from 15 January 2018

Journals and newsletters

• Medicines Safety Update
  Practical information and advice on drug safety and emerging safety issues
• Medical Devices Safety Update
  Medical device safety bulletin