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We are committed to educating advertisers, consumers, health professionals and the therapeutic goods industry to promote voluntary compliance with the import, advertising and supply requirements of the Therapeutic Goods Act 1989 (the Act). Increased compliance with the Act, optimises public health and safety, and builds community trust in the therapeutic goods regulatory framework.
This plan outlines the compliance education priorities and related activities for 2024. This has been developed in consultation with the Therapeutic Goods Advertising Consultative Committee (TGACC) and may be adjusted as needed in response to demand, emerging trends or compliance matters.
This plan aligns with the Import, Advertising and Supply Compliance Priorities 2023-24 which sets out the TGA’s priority areas for compliance activities. It should be read in conjunction with the Therapeutic goods import, advertising and supply compliance education strategy.
Education Priorities
The TGA’s 2024 education priorities are outlined below.
- Communication and education products relating to Import, Advertising and Supply Compliance Priorities 2023-24
- Publish information on compliance and enforcement activities for transparency and as a deterrent to non-compliance
- Maintain and enhance fit-for-purpose educational resources on the TGA website and provide 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
Education Priority 1: Activities related to import, advertising and supply compliance priorities
Unlawful import, advertising and supply of nicotine vaping products (NVPs)
Topic | Activity | Details |
|---|---|---|
General public awareness | Website information, media releases and social media. | Updates to all relevant web content as needed throughout the implementation of the reforms to ensure timely access to up-to-date information and resources. Distribution of media releases, announcements and social media campaigns as applicable. |
Information for importers and sponsors | Website information and guidance material. | Updates to Vaping Hub and related pages such as Notices Provide material such as guidance on obtaining licences and permits and complying with updated standards, developed as needed to support compliance with reforms. |
Information for prescribers and pharmacists | Website information, events and guidance material. | Updates to Vaping Hub and related pages such as SAS and AP pathways. Provide guidance and training material and/or contribute to material developed by stakeholders such as the RACGP and PSA. Host and/or participate in targeted events and forums. |
Information for law enforcement | Website information, events and guidance material. | Updates to Vaping Hub. Design and delivery of support and guidance for Federal, State and Territory enforcement entities in response to identified needs. |
Notices | Safety alerts Notified vape list
| Ongoing and as required when counterfeit products are identified. (See Safety alerts) Publish and update list of notified vapes on TGA website.
|
Unlawful advertising of medicinal cannabis, psilocybin and MDMA
Topic | Activity | Details |
|---|---|---|
Medicinal cannabis | Updated guidance and webinar to industry | Updated advertising guidance for businesses involved with medicinal cannabis. See Advertising guidance for businesses involved with medicinal cannabis products Webinar explainer for industry of the updated medicinal cannabis advertising guidance. |
MDMA and psilocybin guidance | Factsheets and targeted guidance | Targeted delivery of guidance for prescribers and manufacturers. |
Unlawful advertising of unapproved products used in the wellness and beauty industries
Topic | Activity | Details |
|---|---|---|
| Cosmetic-Therapeutic good Interface | Guidance document | Interface guidance for industry on determining which regulatory framework their product fits into. |
| Weight loss products | Web statement/safety alert | Education about the use of weight loss injections such as semaglutide, when compounding becomes manufacturing, risks of unregulated and counterfeit products. |
| Cosmetic injectables | Education including webinars and guidance | Guidance on TGA’s interpretation of applicability of rules for advertising of cosmetic injectables, particularly those containing substances included in Schedule 4 (prescription only medicines) of the Poisons Standard. |
| Unapproved sports supplements | Safety warning | Targeted safety warning for consumers about using unapproved sports supplements and the risks of these goods. |
| Publication of safety alerts | Safety alert | Public warnings of unsafe or counterfeit goods. See Alerts page |
Unlawful import of substandard and falsified therapeutic goods
Topic | Activity | Details |
|---|---|---|
Parallel import of cosmetic injectables
| Targeted fact sheet mailout | Guidance for medical and health practitioners. |
Personal Importation Scheme | Guidance document update | Update guidance document, adding FAQs as appropriate. |
Substandard or Counterfeit medicines | Safety Alerts | Publication of safety alerts related to testing outcomes. |
WHO’s Global Surveillance and Monitoring System, and Rapid Alerts | Targeted guidance mailout | Guidance targeted to health practitioners on what Rapid Alerts are, how they will be disseminated, and the information that should be submitted in order to increase Australia's contribution and ensure substandard and falsified medicines don't put public health at risk. |
Unlawful import, advertising and supply of medicines and medical devices advertised as traditional or alternative treatments
Topic | Activity | Details |
|---|---|---|
High-risk traditional medicines | Guidance document | Guidance for importers and suppliers on high-risk products marketed as traditional medicines, such as those that contain scheduled substances. |
Product testing | Web statement/safety alert | Publication of testing outcomes to warn consumers of products containing high risk ingredients. |
Education Priority 2: Publish information on compliance and enforcement actions for transparency of compliance activities and as a deterrent to non-compliance
Topic | Activity | Details |
|---|---|---|
Import, advertising and supply investigations: information for stakeholders | Publish outcomes of investigations | Ongoing Information on completed investigations into import, advertising and supply matters undertaken by the TGA to promote transparency and compliance. |
Enforcement actions: information for stakeholders | Publish media releases | Ongoing Information on enforcement actions taken by the TGA to promote transparency and compliance. See Media releases |
Warning statements/safety alerts: information for stakeholders | Publish media releases/ Safety alerts | Ongoing as required See Media releases and Safety alerts |
Therapeutic Goods Advertising Compliance Annual Report 2023-24 | 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 Priority 3: Maintain and enhance fit for purpose educational resources, and participate in training and education opportunities
We value stakeholder input and feedback in the preparation of user friendly and relevant guidance. Depending on the topic of the guidance being developed, we may consult with the full or select members of the TGACC, and other impacted or invested stakeholders.
Education campaigns
Activity | Notes | |
|---|---|---|
Education Plan (this document) | Planning document | Working document to determine annual education activities to support the Therapeutic Goods Advertising Compliance Education Strategy. TGACC feedback on education requirements continues to inform the plan |
What we regulate | Social media campaign / website blog | Educate consumers about what the TGA does and doesn’t regulate. Rationale: The Contact Centre frequently gets calls from the public who are not clear about our role. |
Create content that plays by the rules | Social media campaign / website blog | Educate consumers, influencers and retailers about what is allowed when creating content on social platforms, including the dos and don’ts of testimonials. |
Travelling with medicines & medical devices | Social media campaign / translated content | Reinforce messaging regarding how to travel safely with medicines and medical devices. Provide specific examples to address current confusion and information gaps. Develop translated content and promote in-language as part of a paid campaign. |
Compounding | Social media campaign / website blog | Educate consumers on the facts and risks of compounded medicines (e.g. semaglutide). Remind health professionals of their obligations, the regulations and liability risks of compounding medicines. |
TGA website
Topic | Activity | Details |
|---|---|---|
What constitutes advertising | Updated web guidance | Updates to the guidance on what is considered advertising to be clearer for industry/advertisers. |
Advertising hub improvements | Web page updates | Ongoing Update web pages to ensure content is:
|
Development of educational materials to support ongoing advertising compliance
Topic | Activity | Details |
|---|---|---|
Advertising Code guidance | Update guidance as required | Continue to refine guidance to support advertisers to understand the Code requirements based on the needs of stakeholders. |
Emerging matters and trends | Publish website information | As required. Information prepared in response to new or emerging trends relating to advertising, importation and supply regulation. |
Stakeholder engagement
Topic | Activity | Details |
|---|---|---|
TGA stakeholder survey: questions about advertising | Prepare advertising specific questions to include in annual survey about KPIs. | Gain stakeholder input in relation to external view of TGA’s advertising education and compliance programs. |
Education and training
Activity | Details | |
|---|---|---|
Topics as identified | Education and training | Educational activities for external audiences to be developed in consultation with stakeholders. The TGA is often invited to present at different forums on the advertising requirements and its compliance work. |
Regulatory changes and emerging issues | Education, training, guidance | It is an enduring priority for the TGA to educate external audiences in relation to upcoming regulatory changes and any emerging issues. Education and/or training will be developed as required for topics. |
The use of Nicotinamide adenine dinucleotide (NAD) in complementary medicines | Targeted correspondence to industry | Targeted guidance for sponsors about the use of NAD+ in medicine names and advertising. |
Medical device regulation
Topic | Activity | Details |
|---|---|---|
Regulatory basics for medical devices | Website guidance, factsheets, webinars | Guidance for industry and healthcare practitioners on the regulatory basics of medical devices. Including sector and topic specific factsheets and educational webinars. |
Lapses in Conformity Assessment | Updated guidance | Guidance for industry on what to do when there is a lapse in the currency of the manufacturers evidence to support conformity assessment. |
Software based medical devices | Updated guidance | Updated and improved guidance and education resources for software based medical devices. |
European Union Medical Devices Regulation (EUMDR) Transition | Range of updated guidance and web material | Updated guidance for transition to the new EUMDR to assist industry to meet their Australian regulatory obligations. |
Conformity assessment applications | New guidance | New guidance to assist applicants to understand the process of conformity assessment. |
In-vitro diagnostics (IVD) Regulation | Presentation | Stakeholder education with Pathology Technology Australia (PTA) on IVD regulation |
In-house IVD regulation | Presentation | Stakeholder education with National Association of Testing Authorities (NATA) on in-house IVD regulation |
Pre-Submission Guidance | Website guidance, factsheets | In support of reforms, provide sponsors with pre-submission opportunities to have early and timely dialogue with TGA, including to set expectations, transparency on potential audit, timeframes and costs. |
Medical Technology Association of Australia (MTAA) – regulation | Face-to-face training | TGA staff support MTAA to deliver regulatory training to medical device Sponsors and Manufacturers. |
Companion Diagnostics | Guidance consultation | Stakeholder consultation on guidance on ‘Performance requirements for Companion Diagnostics’, |
Education priority 4: Engage with key stakeholders, including members of the TGACC, as partners in education and communication activities
Activity
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 2023-24, as well as in the distribution of education content and messaging. We will:
- Seek member input on education activities through the Education Plan
- Cooperate with TGACC members on preparation of certain education products
- Consult with relevant members of the TGACC, and other relevant TGA consultative committees and working groups, on the preparation of guidance
- Seek assistance from TGACC members to distribute guidance and education
- Seek assistance from relevant TGACC members in preparation and delivery of the mandatory statements in advertising consumer education campaign.
Education priority 5: Maintain and enhance an advertising enquiry management function
Activity
We are committed to maintaining an effective advertising enquiry management function, along with import enquiry management, as part of our ongoing education work.
Trends and issues seen through our enquiry management functions will be used to inform our education work.