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Advertising: Consultation and independent reviews

12 November 2020

The TGA regularly reviews the therapeutic goods regulatory framework through engagement with stakeholder groups, industry and public consultations and independent expert panel reviews.

Therapeutic Goods Advertising Consultative Committee (TGACC)

The TGACC is a collaborative forum that is focused on achieving better outcomes for consumers through effective advertising compliance.

Sectors represented in the TGACC include consumers, media, industry, health practitioners and regulatory bodies involved in the advertising of therapeutic goods to the public.

Its purpose is to:

  • Provide input to policies relating to the administration of the Therapeutic Goods Advertising Code
  • Provide a forum for engagement on emerging issues with respect to therapeutic goods advertising
  • Assist with shaping TGA reporting activities with respect to advertising compliance
  • Provide input on the development of education and compliance priorities to address non-compliance of advertising for particular categories of therapeutic goods.

Find out more about the TGACC.

Industry and public consultations

We conduct consultations as part of our broader stakeholder engagement work, including on changes to regulatory requirements or practices, reviews of business processes, standards and guidelines.

Details of consultations regarding advertising are available through our consultations portal in the news room section of our website.

Find out more about the scope and timeframes involved in our consultation process and how you can participate through a formal submission or by providing feedback.

Independent reviews and outcomes

Many changes have been made to the regulatory framework for advertising of therapeutic goods which reflect the recommendations of formal reviews. These include:

  • Introducing new sanctions and penalties to address non-compliant advertising
  • Updating the Therapeutic Goods Advertising Code (the Code)
  • Improving the process for identifying non-compliant advertising and assessing community risk
  • Removing the requirement for advertising to be approved by TGA prior to placement.

We've also made further educational and guidance materials available to support advertisers.

2020 Sinclair Review of advertising reforms

An independent review was conducted during the first half of 2020 to assess the impact of advertising reforms, initiated by the Expert Panel Review of Medicines and Medical Devices Regulation in 2015.

The review was led by Ms Rosemary Sinclair AM, the newly appointed Chief Executive at auDA.

It was conducted to assess the effectiveness of:

  • Amendments introduced in 2018 to the Code
  • TGA's performance as the single body responsible for managing therapeutic goods advertising non-compliance
  • Increased sanctions and penalties available for TGA to pursue non-compliant advertisers.

It also intended to assess the:

  • Impact of industry and consumer education programs to support new advertising measures
  • Suitability of the TGA's key performance indicators for managing advertising non-compliance
  • Importance of stakeholder engagement activities, particularly the Therapeutic Goods Advertising Consultative Committee.

The Australian Government accepted all 22 recommendations and Ms Sinclair's report is now available for download.

2015 Review of Medicines and Medical Devices Regulation (MMDR)

This review initiated a significant program of reforms to ensure the availability of therapeutic goods met the Australian standards for safety, quality and efficacy.

The MMDR implementation hub brings together information on these reforms including some relating to advertising.

It also includes details about the program status for the MMDR reforms.