Safety information for industry

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.

Recalls & alerts

• Product recalls
  A product recall is the removal of a therapeutic good from supply on the Australian market for reasons relating to their quality, efficacy or safety
• Alerts
  Links to 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 defines the action to be taken by health authorities and sponsors when therapeutic goods for use in humans, for reasons relating to their quality, safety or efficacy, are to be removed from supply or use, or subject to corrective action
• 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

• Human blood & tissues recall report form
  This form is used to report recalls of human blood and tissue products
• 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

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
• Adverse event monitoring internationally
  Worldwide, a number of regulatory agencies make information about reported adverse events publically available

Transmissible spongiform encephalopathies (TSEs)

• TGA approach to minimising the risk of exposure to Transmissible Spongiform Encephalopathies (TSEs) through medicines and medical devices
  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 requirements for therapeutic goods for minimising the risk of transmitting transmissible spongiform encephalopathies (TSEs)
  Guidance on the management of TSE risks associated with putatively 'low-risk' ingredients
• Transmissible spongiform encephalopathies (TSEs) questionnaire for sponsors
  This questionnaire has been designed by the TGA in consultation with Australian industry bodies to facilitate the collection of data to enable Sponsors to self-certify their therapeutic goods against the TGA's 'Supplementary requirements for therapeutic goods for minimising the risk of transmitting transmissible spongiform encephalopathies (TSE)'
• BSE risk associated with the use of materials of bovine origin during the manufacture of vaccines
  These questions and answers explain the BSE related issues associated with vaccines registered by the TGA