Latest news & updates
This page shows the last 20 updates that have been made to the TGA website and includes product recalls, alerts and media releases/statements issued by the TGA in recent weeks.
The TGA also has a number of email lists to which you can subscribe to receive updates by email.
21 May 2013
Revised code of GMP for human blood and tissues
The Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013 commences on 31 May 2013
21 May 2013
Business process review: minor variations to prescription medicines - for sponsors
On 22 May 2013 the TGA will introduce changes to administrative processes for making minor variations to prescription medicines
21 May 2013
Australian regulatory guidelines for prescription medicines (ARGPM)
Updated information for Appendix 12 and Appendix 13
20 May 2013
Squid oil: Draft compositional guideline
Draft compositional guideline for Squid Oil. Closing date: 1 July 2013
20 May 2013
Cancellations from the ARTG following compliance review
Added two products cancelled from the ARTG following compliance review
17 May 2013
The Poisons Standard (the SUSMP)
Updated the SUSMP section and added SUSMP No.4 forms
16 May 2013
CoaguChek INR monitors
Health professionals and consumers are advised that Roche Diagnostics Australia, after consultation with the TGA, has initiated a recall for product correction for its CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro INR monitors
16 May 2013
Gardasil (quadrivalent human papillomavirus vaccine)
The TGA has continued to monitor the vaccine, including monitoring reports of suspected adverse events in Australia and data from international sources, and continues to consider Gardasil to be safe and effective
16 May 2013
Australian Vaccination Network Inc "Black Salve" (Complaint No. 2012-04-022)
Decision under regulation 9 of the Therapeutic Goods Regulations 1990 in relation to an advertisement about the product 'black salve'
16 May 2013
Submissions and TGA response: Proposed advisory statements for medicines - Cetirizine
Submissions received in response to the consultation and TGA response
16 May 2013
Advisory Committee on Medical Devices (ACMD)
The ACMD meeting for 28 June 2013 has been cancelled
16 May 2013
Advisory Committee on Complementary Medicines (ACCM)
Added ACCM meeting date for 2 August 2013 and meetings scheduled for 14 June and 6 September 2013 have been cancelled
16 May 2013
Advisory Committee on Biologicals (ACB)
The ACB meeting for 20 June 2013 has been cancelled
16 May 2013
Winter warning - correct and safe use of heat packs
The Therapeutic Goods Administration (TGA) is reminding consumers of potential health risks associated with using wheat or grain-filled heat packs
15 May 2013
Premarket scrutiny of implantable medical devices
The RIS exposure draft outlines 3 options for reforms to premarket scrutiny of implantable medical devices
15 May 2013
ACB meeting statement, Meeting 2, 18 April 2013
The ACB provides advice to the TGA on matters relating to the inclusion, variation, removal or continued inclusion of biologicals (cell and tissue therapy products) on the ARTG
15 May 2013
Consultation: International harmonisation of ingredient names
The TGA is seeking comments on proposed changes to approximately 472 ingredient names, and an update to the guidance document TGA Approved terminology for medicines
14 May 2013
Minor variations to registered prescription medicines: Chemical entities
This document provides guidance for making minor variations to existing ARTG entries
14 May 2013
Minor variations to registered prescription medicines: Biological medicines
This document provides guidance for making minor variations to existing ARTG entries
14 May 2013
Orphan drugs
Added Anakinra (KINERET)
Web page last updated: Thursday, 28 March 2013
URL: http://www.tga.gov.au/newsroom/news-latest.htm