Our commitment is to educate advertisers, consumers, health professionals and industry to promote voluntary compliance with the advertising requirements of the Therapeutic Goods Act 1989.
We will increase compliance with the advertising requirements in a way that optimises public health and safety and builds community trust.
The table below outlines the compliance education priorities. Activities against these priorities are provided in the following tables. The education activities are consulted on with the Therapeutic Goods Advertising Consultative Committee at each meeting and will be adjusted as appropriate to meet demand for specific products.
Education priorities
- Plan for and develop communication and education products as part of the Compliance Plans for the agreed advertising compliance priorities.
- Timely communications on regulatory changes and emerging issues.
- Publish information on compliance and enforcement actions for transparency of compliance activities and as a deterrent to non-compliance.
- Maintain and enhance fit for purpose educational resources and participate in training and education opportunities.
- Engage with key stakeholders, including members of the TGACC, as partners in education and communication activities.
- Maintain and enhance an advertising enquiry management function.
This plan should be read in conjunction with the Therapeutic Goods Advertising Compliance Education Strategy 2021.
| Topic | Education activity | Status/key messaging |
|---|---|---|
| Compliance Priority - COVID-19 products | ||
|
COVID-19 vaccines |
Fact sheet |
Guidance on the use of Government materials to promote COVID-19 vaccines |
|
COVID-19 vaccines |
Direct engagement and education |
Current and continued - phone calls and emails to discuss and clarify guidance on promoting COVID-19 vaccines |
|
COVID-19 vaccines |
Web updates |
Information on matters arising from compliance activities |
|
Hand sanitisers |
Case study |
(drafted) for consultation, endorsement and publication |
|
Test kits on ARTG |
Case study |
(drafted) for consultation, endorsement and publication |
|
Self-test kits |
Case study |
(drafted) for consultation, endorsement and publication |
| Compliance Priority - Stem Cells | ||
|
Stem cell therapies |
Guidance |
|
|
Stem cell therapies |
Media release |
Media release advising of the TGA's compliance focus on advertising of stem cell therapies |
|
Stem cell therapies |
Case study |
Advertising factsheet targeted at consumers |
|
Stem cell therapies |
Case study |
Advertising factsheet targeted at advertisers |
|
Stem cell therapies |
Case study |
Advertising factsheet targeted at health professionals |
|
TBA |
TBA |
Additional education activities to be determined through the compliance plan |
| Compliance Priority - Medicinal Cannabis | ||
|
Medicinal cannabis |
Guidance document |
|
|
Medicinal cannabis |
Webinars x 2 hosted by TGA, MCIA and AMCA |
Joint presentations, hosted by the TGA, to clarify the advertising rules and responsibilities Medicinal Cannabis Advertising Compliance 3 March 2021 (archived) |
|
Supply of unapproved products - compliance with 'direct control' |
Direct engagement via letter |
Targeted letters regarding 'direct control' (Schedule 5A Therapeutic Goods Regulations) and how to comply with the rules for supply of unapproved products |
|
Case study |
Case study |
(drafted) Case study of a Facebook post for publication |
|
TBA |
TBA |
Additional education activities to be determined through the compliance plan |
| Compliance Priority - Performance and image enhancing drugs | ||
|
Sports supplements |
Webinar x 2 |
Clarify advertising requirements following the section 7 declaration |
|
Advertising prescription only medicines (SARMs) |
Case study |
(drafted) for publication |
|
Sports supplements |
TBA |
Additional education activities to be determined through the compliance plan |
| Compliance Priority - Therapeutic goods used in beauty industry | ||
|
Unregistered sunscreens |
Case study |
(drafted) for publication |
|
Schedule 4 Botox |
Case study |
(drafted) for publication |
|
Guidance re cosmetic/therapeutic goods interface |
Guidance/fact sheet |
(drafted) for publication |
| Topic | Education activity | Status/key messaging |
|---|---|---|
| Changes to the advertising complaints handling framework | ||
|
New reporting process |
Web information |
Update to website information regarding 'how to report non- compliant advertising' in conjunction with new system implementation |
|
New process |
Web information |
Update to website information regarding how we manage advertising compliance |
|
Tips |
Fact sheet |
(update to previous publication) 10 things to look out for in advertising |
|
Reporting process |
Fact sheet |
Overview of advertising compliance management for consumers, including how to lodge report |
| Medical device reforms | ||
|
Changes to legislation |
Fact sheet |
Advertising basics fact sheet focusing on medical devices |
|
Changes to legislation |
Guidance document |
Addressing personalised medical devices, equipment and Software as Medical Devices |
|
Changes to legislation |
Fact sheet |
Addressing personalised medical devices, equipment and Software as Medical Devices |
| Changes to the Advertising Code | ||
|
Code Review |
Direct engagement |
TGACC updates |
|
Code Review |
Public engagement |
Public consultation on proposed changes to the Advertising Code |
|
Code Review |
Webinars |
Public consultation on proposed changes to the Advertising Code |
|
Code implementation |
Web statements and direct engagement |
To inform stakeholders about the new Advertising Code |
|
Code implementation |
Guidance and fact sheets |
Updates to guidance and fact sheets |
| Essential Oils | ||
|
Direct Sellers |
Guidance document |
Guidance document produced for advertisers (direct sellers) of essential oils |
| General advertising | ||
|
Advertising directed to health professionals |
Fact sheet |
|
|
Use of 'TGA approved' in advertising |
Fact sheet |
|
| Status / Key messaging |
|---|
|
Publish the outcome of advertising investigations Publish media releases when higher level enforcement actions are taken, as appropriate Publish Therapeutic Goods Advertising Compliance Annual Report 2020-21 |
| Topic | Education activity | Status / key messaging |
|---|---|---|
| Annual Education Plan | ||
|
Annual Education Plan |
Working document |
Working document to set education activities linking to the Therapeutic Goods Advertising Compliance Education Strategy. TGACC feedback on education requirements continues to inform and update the plan |
| Advertising Hub improvements | ||
|
Central repository for Fact Sheets |
Fact sheets |
To consolidate all fact sheets into a central location for ease of access and use |
|
Publication of new case studies |
Case Studies |
Ensuring suite of case studies are published and located centrally for ease of access and use |
|
Identify and update broken links |
General updates |
To ensure content is current |
|
ARGATG |
General improvement |
For consideration - work with Regulatory Guidance team to improve the way the ARGATG is presented on the TGA website (currently any updates to the guidance require removal and republication of entire document) |
| Development of educational materials to support ongoing advertising compliance | ||
|
Code guidance |
Align with amended Code |
Code guidance to be amended to reflect any changes made to the Advertising Code |
|
ARGATG |
Additional content |
Continue to add content to the ARGATG, with a focus on providing additional guidance on conducting information sharing activities (e.g. ASX announcements, conferences) without being promotional. |
|
ASX announcements |
Additional content |
Requirements and obligations for writing ASX announcements |
|
Various, emerging, as required |
Case Studies |
Case studies to support advertising requirements related to emerging and compliance topics |
|
Various, emerging, as required |
Guidance documents |
Guidance on application of the legislation |
|
Various, emerging, as required |
Fact sheets |
Summary documents to highlight advertising issues and provide tips and advice |
|
Various, emerging, as required |
Web pages |
To alert audience to new topics or emerging issues |
|
Various, emerging, as required |
Webinars, training materials |
Information sharing and training |
|
Various, emerging, as required |
Social media |
Alerts, advice. Promotion of call to action |
| TGA stakeholder survey | ||
|
Stakeholder survey |
Planning |
Include agreed advertising questions in the TGA Stakeholder Survey in support of KPI reporting |
| Reporting | ||
|
Therapeutic Goods Advertising Compliance Annual Report |
Reporting |
The annual report includes an analysis of advertising compliance during the year and promotes transparency by providing information about the TGA's compliance and enforcement work throughout the year |
|
TGA annual reporting |
Reporting |
Information provided as part of the TGA's annual performance reports |
| Education and training | ||
|
Topics as identified |
Education and training |
Educational activities for external audiences |
|
Topics as identified |
Training |
Training for TGA staff in line with the Regulatory Compliance Branch Training Framework |
| Status / key messaging |
|---|
|
When preparing education activities we will ensure that the audience for each activity is identified, that suitable channels of communication are selected and that activities cover a relevant range of topics. Industry membership of the Therapeutic Goods Advertising Consultative Committee (TGACC) reflects representation from key sectors of the therapeutic goods industry. The TGACC will take a pivotal role in helping to guide and shape the education activities for 2021, as well as in the distribution of education content and messaging. |
| Status / key messaging | Anticipated completion by |
|---|---|
|
We are committed to maintaining an effective enquiry management function. Trends seen through our enquiry management function, informed by reporting from our new IT system (go live late July 2021), will be used to inform our education work. |
Ongoing |