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 our compliance education priorities and related activities for the 2024-25 period. 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 2023-25, which sets out our priority areas for compliance activities. It should be read in conjunction with the Therapeutic goods import, advertising and supply compliance education strategy.
Education priorities
Our 2024-25 education priorities are outlined below.
- Communication and education products relating to Import, Advertising and Supply Compliance Priorities 2023-25
- 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 vaping 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 Royal Australian College of General Practitioners (RACGP) and the Pharmaceutical Society of Australia (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 the TGA website. |
Unlawful advertising of medicinal cannabis, psilocybin and MDMA
| Topic | Activity | Details |
|---|---|---|
| Medicinal cannabis | Guidance update | Review guidance as part of developing comprehensive guidance on advertising prescription-only medicines and to meet new accessibility standards. |
Unlawful supply and advertising of unapproved products used in the wellness and beauty industries
| Topic | Activity | Details |
|---|---|---|
| Sport supplements and Performance and Image Enhancing Drugs (PIEDs) | Consumer Information | Develop consumer educational material on the risks of sports supplements and PIEDS. |
| Publication of safety alerts | Safety alerts | Public warnings of unsafe or counterfeit goods. See alerts page. |
| Compounding Activities | Guidance document | Consolidated guidance on the regulations relating to extemporaneously compounded medicines and how to legally advertise these services. |
| Prescription medicines | Guidance update | Consolidating multiple industry-specific guidelines into a single document to provide a more comprehensive guidance on the rules about advertising prescription medicines. |
| Unapproved wellness and beauty products | Website information and guidance material | Information for consumers and practitioners in relation to imports of unapproved wellness and beauty products. |
| Caffeine pouch importation | Guidance | Develop guidance on the regulations for the importation of caffeine pouches. |
Unlawful import and supply of substandard and falsified therapeutic goods
| Topic | Activity | Details |
|---|---|---|
| Personal Importation Scheme and Traveller’s Exemption | Web page updates | Updates to information for consumers to provide greater clarity on the scheme and exemption requirements. |
| Substandard or Counterfeit medicines | Safety alerts | Publication of safety alerts related to testing outcomes. |
| WHO’s Global Surveillance and Monitoring System, and Rapid Alerts | Information for practitioners | Information 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. |
| Erectile Dysfunction Medication | Consumer information | Develop educational information for consumers about the risks associated with purchasing erectile dysfunction medication online. |
| Medical devices | Consumer and industry information | Develop educational resources to help consumers understand what qualifies as a medical device, what to consider when purchasing one and how to identify which devices are approved for sale and use in Australia. |
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 statements Safety alerts | 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 |
|---|---|---|
| Enforcement actions: information for stakeholders | Publish media releases | Ongoing Information on enforcement actions taken by us 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 |
| TGA annual reporting | Reporting | Information provided as part of the our annual performance reports including insights into compliance, enforcement activities and advertising compliance analysis. |
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
| Topic | Activity | Notes |
|---|---|---|
| Various | Social media campaign / website blog | We will deliver several paid public awareness campaigns in the 2024-25 financial year. These topics are informed by upcoming regulatory changes, health literacy or knowledge gaps, internal and external stakeholder feedback, and can be adjusted to take account of emerging issues. |
TGA website
| Topic | Activity | Details |
|---|---|---|
| Advertising hub improvements | Web page updates | Ongoing Update web pages to ensure content is:
|
| Compliance and enforcement pages | Web page updates | Consolidation of web pages to provide a simpler and more user-friendly guide to compliance and enforcement actions. |
Development of educational materials to support ongoing advertising compliance
| Topic | Activity | Details |
|---|---|---|
| Advertising Code guidance | Guidance update | Updates to the Advertising Code guidance to refresh examples, simplify language and improve readability. |
| 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. |
| Advertising unapproved products | Web page update | Update the web pages on adding goods to the ARTG. Increase clarity and emphasis on the prohibition on advertising unapproved goods. Highlighting how to check if goods are already on the ARTG. |
| Social media advertising | Guidance update | Updates to the social media guidance addressing gaps and reflect the evolving use of social media platforms to advertise therapeutic goods. |
| Activities that represent advertising | Guidance update | Updates to more clearly outline activities likely to be considered advertising therapeutic goods. |
| Advertising health services | Guidance update | Updates to reduce duplication of content across related guidance material and provide greater clarity for industry. |
| Advertising basics | eLearning modules for advertisers | Educational eLearning modules covering advertising basics for sponsors and advertisers. |
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 our 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. We are 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 us 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. |
| Melatonin | Information for consumers and practitioners | Information for medical practitioners and consumers on the import, use and risks of unregistered melatonin. |
| Importing therapeutic goods | Web content | Update current web content to highlight the safety risks of importing therapeutic goods and the potential penalties or prosecution for illegal imports. |
| Media broadcasters | Guidance document | Develop a guidance document for publishers and broadcasters on complying with advertising requirements when communicating about therapeutic goods. |
| Restricted Representations | Guidance document | Develop updated guidance on making applications for restricted representations. |
| The use of permissible indications relating to hangover and overindulgence in alcohol for listed medicines | Targeted correspondence to industry | Targeted guidance for sponsors to raise awareness about the requirements for use of these indications in medicine names and advertising. |
| Requirements for use of permissible indications in listed medicines | Targeted correspondence to industry | Targeted guidance for sponsors of listed medicines with numerous indications to raise awareness about the requirements relating to holding evidence to support each indication. |
Medical device regulation
| Topic | Activity | Details |
|---|---|---|
| Regulatory basics for medical devices | 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 | 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 and AI- based medical devices | Updated guidance | Updated and improved guidance and education resources for software and artificial intelligence (AI)-based medical devices. |
| European Union Medical Devices Regulation (EUMDR) Transition | Range of guidance and web material | Guidance for transition to the new EUMDR to assist industry to meet Australian regulatory obligations. |
| Conformity assessment applications | Guidance | Guidance to assist applicants to understand the process of conformity assessment. |
| Pre-Submission Guidance; | Guidance and factsheets | In support of reforms, provide sponsors with pre-submission opportunities to have early and timely dialogue with us, including to set expectations, transparency on potential audit, timeframes and costs. |
| Medical Device Vigilance Program | Guidance | Pilot program to support sponsors with post market requirements. |
| Companion Diagnostics | Guidance consultation | Stakeholder consultation on guidance on ‘Performance requirements for Companion Diagnostics’. |
| TGA feedback to industry about audit nonconformities | Guidance | Publishing of quality management system (QMS) nonconformity analysis from on-site and remote audits of domestic and overseas medical device manufacturers. |
| Vaping, including amendments to CtS and PMR sponsor portals to allow for submissions | Guidance and webinars | Guidance for sponsors of nicotine and cannabis vape devices and accessories on post-market responsibilities, how to apply for consent to supply, how to respond to requests for information, and upcoming changes in legislation. |
| Patient Information Leaflets (PILs) | Website material and targeted correspondence | Web material to support industry uploading PILs and health professionals and consumers on how to find PILs. E-mails to stakeholders to advise them of the availability of PILs electronically. |
| Product specific guidance pieces | Guidance | Updated guidance for various product types outlining updated regulatory requirements. |
| System or procedure packs (SOPPs) (SLK) | Guidance | Revised guidance for systems or procedure packs, including surgical loan kits. |
Education priority 4: Engage with key stakeholders, including members of the TGACC, as partners in education and communication activities
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. TGACC will take a pivotal role in helping to guide and shape the education activities for 2024-25, 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
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.