TGA Compliance Priorities for Therapeutic Goods Import, Advertising, and Supply 2023-25

1. Overview

The Therapeutic Goods Administration (TGA) has established compliance priorities for the import, advertising, and supply of therapeutic goods under the Therapeutic Goods Act 1989 for the period 2023-25, with continued focus into 2024-25. These priorities aim to improve public safety, address serious breaches, and target high areas of non-compliance. Activities include intelligence gathering, education, collaboration with agencies, and targeted projects. The priorities complement proposed regulatory reforms and are detailed for 1 July 2024 to 30 June 2025. Note that this guidance has been superseded by Compliance Principles for 2026-2027. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement/import-advertising-and-supply-compliance-priorities-2023-25

2. Key Compliance Priorities

The TGA focuses on five main areas:

2.1 Nicotine Vaping Products

Detect, deter, and disrupt unlawful import, advertising, and supply. Australians, especially youth, are vulnerable to risks from undeclared nicotine. Actions include intelligence use, collaboration with agencies, and targeting unlawful advertising on digital platforms. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement/import-advertising-and-supply-compliance-priorities-2023-25

2.2 Medicinal Cannabis, Psilocybin, and MDMA

Deter and disrupt unlawful advertising. Public promotion is illegal and may influence demand inappropriately. Actions: industry engagement, education on obligations, intelligence gathering, compliance projects, and collaboration with Ahpra. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement/import-advertising-and-supply-compliance-priorities-2023-25

2.3 Wellness and Beauty Industry Products

Detect and disrupt unlawful supply/advertising of unapproved/high-risk medicines and devices (e.g., sports supplements, weight loss meds, injectables). Consumers seeking performance/appearance enhancement are vulnerable. Actions: industry engagement, community education, intelligence, compliance projects, and digital platform targeting. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement/import-advertising-and-supply-compliance-priorities-2023-25

2.4 Substandard and Falsified Therapeutic Goods

Detect, deter, and disrupt unlawful import/supply, focusing on high-risk substances (e.g., Schedule 4/8 poisons). Vulnerability increases with shortages or perceived low-risk. Actions: education, intelligence (including lab testing), compliance projects, information sharing with agencies, and international collaboration (Interpol, WHO via Operation Pangea). Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement/import-advertising-and-supply-compliance-priorities-2023-25

2.5 Traditional or Alternative Treatments

Detect, deter, and resolve unlawful import, advertising, and supply, especially with risky substances (poisons, heavy metals). Vulnerable groups include those with serious conditions. Actions: intelligence gathering, information sharing, and digital platform targeting. Source: https://www.tga.gov.au/s Unic/safety/compliance-and-enforcement/compliance-management-enforcement/import-advertising-and-supply-compliance-priorities-2023-25

3. Additional Activities

Routine monitoring of digital/social media advertising continues, with actions for detected non-compliance. Other programs (e.g., complementary medicines, medical devices post-market reviews) are managed separately. Priorities may be added during the year. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement/import-advertising-and-supply-compliance-priorities-2023-25