Therapeutic Goods Advertising and Compliance Education Plan 2024

The TGA has published a web page outlining the Therapeutic Goods Advertising and Compliance Education Plan for 2024. This plan is stated to align with the TGA’s Import, Advertising and Supply Compliance Priorities 2023-24 which sets out the TGA’s priority areas for compliance activities. The plan should be read in conjunction with the Therapeutic goods import, advertising and supply compliance education strategy

Broadly, the education priorities are stated to include: 

  • Activities related to import, advertising and supply compliance priorities; 
  • The publication of information on compliance and enforcement actions for transparency of compliance activities and as a deterrent to non-compliance; 
  •  The maintenance and enhancement of fit for purpose educational resources, and participation in training and education opportunities; 
  • Engagement with key stakeholders, including members of the Therapeutic Goods Advertising Consultative Committee (TGACC), as partners in education and communication activities; and  
  • The maintenance and enhancement of an advertising enquiry management function. 

Information for members on relevant aspects of each education priority to listed medicines is provided below. 

Regarding the development of new or updated guidance, the TGA has provided that stakeholder input and feedback may be sought from members of the TGACC, of which CMA is a member, and other impacted or invested stakeholders in the preparation of user friendly and relevant guidance. 

In addition, CMA, in collaboration with the CMA regulatory committee, are developing proposals to recalibrate the TGA’s approach to advertising compliance reviews and how the TGA prioritise them in the future. These proposals are intended to provide justification to the TGA on why certain areas are low risk/of low importance requiring reduced TGA compliance focus, and identifying areas requiring increased compliance focus. If members have examples of TGA approaches to advertising that are perceived as non-commensurate with risk, this information and supporting reasons can be provided to CMA via technical@cmaustralia.org.au with a view for inclusion in CMA proposals.  

  1. Activities related to import, advertising and supply compliance priorities 
  • Unlawful advertising of unapproved products used in the wellness and beauty industries; and 
  • Unlawful import of substandard and falsified therapeutic goods 
Topic Activity Details 
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. 

Regarding ‘traditional or alternative treatments’, the TGA’s Import, Advertising and Supply Compliance Priorities 2023-24 are provided below.  

Compliance priority Focus 
Detect, deter and resolve the unlawful import, advertising and supply of medicines and medical devices advertised as traditional or alternative treatments, particularly those that contain substances that pose a risk to human health and/or safety. Some Australians are vulnerable to those intent on profiting from the sale of unregistered therapeutic goods marketed as traditional or alternative treatments. This is of increased concern where the goods contain higher-risk substances including Schedule 4 and Schedule 8 poisons and heavy metals. Consumers that have or are facing a serious disease or condition with limited treatment options may be particularly vulnerable to advertising claims. In addition to responding to high-risk allegations of non-compliance regarding these products we will: gather and use intelligence to identify higher-risk products and trends share information with other health and law enforcement agencies to enhance understanding of supply chains and usage patterns target advertising of unapproved products on digital platforms. 
  1. The publication of 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. 
  1. Maintain and enhance fit for purpose educational resources, and participate in training and education opportunities 
  • Education campaigns 
Topic Activity Notes 
Education Plan  (subject of this alert) 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: accurate and up to date not duplicated easy to find 
  • 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 
Topic 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. 

NAD+ background 

In 2022 the TGA provided that the rationale for prioritising the use of NAD+ in medicine names and advertising was that it is involved in numerous metabolic processes in the body, and given its importance in metabolic pathways, there is a risk that listed medicines containing NAD+ are implied for use to treat or prevent serious conditions (such as diabetes, heart disease, Alzheimer’s disease) as well as anti-ageing. The TGA also provided that some sponsors had also used ‘NAD’ as part of the medicine name to imply uses that are not permitted for listed medicines. 

CMA’s response to the TGA’s proposal to prioritise NAD+ included that: 

  • There are various chemical compounds that are involved in numerous metabolic processes in the body; this does not mean they are implying their use can treat or prevent serious conditions unless there is other advertising or presentation aspects that support this conclusion; 
  • The Permissible Indications Determination specifies the indications that can be used according to the evidence held by a sponsor; 
  • A medicine may use structure-function claims describing certain actions which are related to the permissible indications.  

CMA’s previous feedback to the TGA on issues concerning medicine names perceived to be at risk of non-compliance by the TGA, including those relating to NAD+, also emphasised that that non-compliance can only be fully determined when taking into account overall presentation, not just the medicine name. CMA also noted that the level of risk should be assessed to determine whether compliance action is a worthwhile pursuit based on level of compliance issue or risk. 

  1. Engage with key stakeholders, including members of the TGACC, as partners in education and communication activities 
  • The TGA has provided that they 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. 
  • The TGA has provided that 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. Through this engagement the TGA 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. 
  1. Education priority 5: Maintain and enhance an advertising enquiry management function 

The TGA has provided that they are committed to maintaining an effective advertising enquiry management function, along with import enquiry management, as part of their ongoing education work. Trends and issues seen through the TGA enquiry management functions will be used to inform our education work. 

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