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Safety information

Links to safety information about therapeutic products

  • 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.
    • Current year alerts
      Links to alerts issued by the TGA during the current year.
    • All alerts
      Links to alerts issued by the TGA since 1998
    • About alerts
      Alerts provide important information and recommendations about therapeutic goods.
  • Early warning system

    The Early Warning System includes current and historical information on safety concerns for medicines and medical devices that the TGA has identified through its therapeutic product vigilance program.

    • About the Early Warning System
      Information about the two types of communications in the Early Warning System
    • Monitoring communications
      Monitoring communications aim to highlight potential safety issues with therapeutic products and to increase the available information on these potential safety issues by encouraging reporting of problems.
  • Reporting problems
    The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices
  • Safety information & education
    Links to advice and educational materials about the safety of therapeutic goods.

Consumers

Links to information for consumers about therapeutic goods, such as medicines and medical devices

Health professionals

Links to information for health professionals about medicines and medical devices.

Industry

Links to information about the regulation of therapeutic goods in Australia.

About the TGA

The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.

  • TGA basics
    The TGA is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose.
    • Who we are & what we do
      The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods.
    • What the TGA doesn't do
      Information about what the TGA doesn't do
    • TGA structure
      The Therapeutic Goods Administration (TGA) is a division of the Australian Government Department of Health and Ageing.
    • TGA plans & reports
      Links to TGA plans and reports, including annual reports, business plans, legal expenditure reports, records listings
    • Freedom of information
      The Freedom of Information Act 1982 is designed to give the Australian community access to information held by the Commonwealth Government.
    • TGA reforms
      The TGA is focusing on implementing changes to ensure a greater emphasis on transparency of regulatory decision-making processes, a continuing focus on business process reform and a more strategic approach to the use of information technology to support regulatory operations.
    • Acronyms & glossary
      A list of acronyms and glossary terms likely to be found within Therapeutic Goods Administration information.
    • Publications
      Links to TGA publications
    • Forms
      Links to TGA forms
    • TGA Internet site
      Links to information about the TGA Internet site.
  • Contact the TGA
    You can contact the TGA using the options below. Our main office is located in Symonston, ACT.
  • Educational materials
    This section contains links to educational materials for consumers, health professionals, industry, and university students.
    • University student educational materials
      These presentations have been designed specifically for university students who are studying to become health professionals and are in the later stages of their degrees. We hope they'll be a useful supplement in the lecture theatre .
  • Regulatory compliance
    The TGA uses a staged risk- management approach to compliance that attempts to identify entities at risk of unintentional or deliberate non-compliance and enable the development of appropriate strategies to prevent non-compliance
    • Regulatory compliance framework
      The TGA employs a combination of monitoring strategies to support its compliance program
    • Compliance actions
      Section 61(5A) of the Therapeutic Goods Act 1989 provides that the Secretary may release to the public therapeutic goods information relating to any decision or action taken under this Act or the regulations. It is TGA practice to publish details of regulatory compliance decisions and actions on its website.
    • Compliance undertaking
      A person (including a company) who believes they have, or are likely to have breached an offence or civil penalty provision in the TGA legislation, can apply to enter into a written undertaking as an alternative to court action being commenced by the TGA
  • Committees
    Definitions and links to information about Therapeutic Goods Administration committees
  • Employment & job vacancies
    If you want to join our team and can meet our job requirements, we invite you to apply for one of our positions.
    • Working for the TGA
      The TGA protects public health and safety by regulating medicines and medical devices manufactured, imported, supplied in and exported from Australia.
    • Recruitment information
      If you are interested in joining our team and can meet our job requirements, we invite you to apply for one of our positions
  • Fees & payments
    The TGA is fully cost-recovered and collects its revenue primarily through annual charges, evaluation and assessment fees and licence fees.
  • TGA eBusiness Services
    TGA eBusiness Services establishes a base for electronic commerce, electronic lodgement of data packages in support of applications for entry of products onto the Australian Register of Therapeutic Goods and enables online client access to legally appropriate information.
    • About TGA eBusiness Services
      TGA eBusiness Services is the TGA's platform for electronic commerce and lodgement of data packages in support of applications for entry of products onto the ARTG
    • eBusiness Services forms
      These forms are used by sponsors, agents and manufacturers to apply for access to TGA eBusiness Services
    • PI/CMI search facility
      The CMI is a leaflet about the safe and effective use of a medicine. The PI provides health professionals with a summary of essential scientific information about a medicine.
  • International
    Information about the TGA's international activities and links to international organisations involved in the regulation of therapeutic goods.
    • International activities
      As an internationally-respected regulator, the TGA is involved in many activities with overseas organisations
    • International cooperation
      The TGA works closely with overseas regulatory agencies and has a number of agreements with them
    • TGA international engagement strategy 2013-2015
      The TGA International Engagement Strategy provides the overarching direction for TGA's international engagement for 2013-2015 and articulates TGA's key international business priorities: driving the regulatory harmonisation process; establishment of the Australian New Zealand Therapeutic Products Authority (ANZTPA); ensuring the integrity of the supply chain; and delivering regional and global public health responsibilities
    • Links to international agencies & organisations
      Links to websites of international agencies and organisations related to therapeutic goods regulation
  • TGA Internet site archive
    The content in the TGA Internet site archive is provided to assist research and may contain references to activities or policies that have no current application

News room

Links to news and updates about the regulation of therapeutic goods in Australia and activities of the TGA.

Content last updated: Wednesday, 2 February 2011

Web page last updated: Wednesday, 2 February 2011

URL: http://www.tga.gov.au/about/website-sitemap.htm