The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries.

The pages linked below contain information for sponsors and manufacturers.

On this page: Recalls & alerts | Reporting problems | PI/CMI | Safety monitoring | Transmissible spongiform encephalopathies (TSEs)

Recalls & alerts

• Recalls
  A recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation
• Alerts
  Safety alerts and advisory statements about medicines and medical devices in Australia
• Uniform recall procedure for therapeutic goods (URPTG)
  The uniform recall procedure for therapeutic goods provides a consistent approach for undertaking recall and non-recall actions of therapeutic goods supplied, imported into or exported from Australia
• Product contamination & extortion - a protocol for the therapeutic goods industry
  Developed by the Industry Government Crisis Management Committee as a joint industry-government initiative, with the aim of assisting managers in responding to a product contamination and/or extortion event directed at the therapeutic goods industry

Reporting problems

• Biologicals (including tissues) human blood and blood components recall report form
  This form is used to report recalls of biologicals and human blood and blood components
• Report a medical device adverse event (sponsor/manufacturer)
  This form is to be used by medical device manufacturers or authorised representatives for mandatory reporting of adverse events associated with a medical device

Product Information/Consumer Medicine Information

• Improved Consumer Medicine Information template
  9 September 2019 The TGA, in consultation with consumer, health professional and pharmaceutical industry representatives, has developed an improved template for CMI
• Product Information (PI)
  A new Product Information (PI) form was approved on 8 November 2017, with a commencement date of 1 January 2018. The new format is being introduced with a 3 year transition period, ending 31 December 2020.

Safety monitoring

• Medicines safety monitoring
  How the safety of medicines is monitored, including guidelines for sponsors and manufacturers
• Medical devices safety monitoring
  How the safety of medical devices is monitored, including guidelines for sponsors and manufacturers

Transmissible spongiform encephalopathies (TSEs)

• Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure
  TSEs, caused by agents known as prions, include scrapie in sheep and goats, chronic wasting disease in deer, bovine spongiform encephalopathy (BSE) in cattle, and Kuru and Creutzfeldt-Jacob Disease (CJD) in humans
• Supplementary information on Transmissible Spongiform Encephalopathies (TSEs) regulation
  Supplementary information on changes the TGA has made in updating its approach to minimising the transmission of Transmissible Spongiform Encephalopathies (TSEs)