TGA Compliance Management and Enforcement Policy: Framework and Principles

1. Purpose

The Therapeutic Goods Administration (TGA) monitors and enforces compliance with Australian laws regulating the import, export, manufacture, advertising, and supply of therapeutic goods. This ensures that medicines and medical devices are safe and fit for their intended purpose, protecting consumers and maintaining a fair market for industry. The TGA does not regulate health services (except therapeutic goods aspects), medical practitioner conduct, drug offences investigated by police, or general consumer goods. Relevant concerns may be referred to state/territory health departments, Ahpra, ACCC, or fair trading agencies. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement

2. Guiding Principles

TGA compliance activities are based on:

• Encouraging voluntary compliance through education and guidance.
• Prioritising work based on risks to public health, safety, and confidence in regulation.
• Ensuring actions are evidence-based and proportionate to the breach and the entity's compliance approach.
• Committing to transparency by reporting enforcement actions and outcomes. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement

3. Risk-Based Approach

Detection and Assessment

Monitoring is proactive and responsive, using signals from internal/external sources, including public reports (confidential/anonymous options available via the report a breach page). All signals are recorded. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement

Assessment and Case Selection

Not all matters are pursued due to volume; priority is given to risks to public safety, serious breaches of the Therapeutic Goods Act 1989, or repeated/wilful non-compliance. Assessments consider regulation applicability, consumer harm risk, breach nature, target market vulnerability, and entity compliance history. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement

4. Factors Influencing Actions

Actions are determined case-by-case, considering public safety risk, breach seriousness, compliance history, entity size/reach, market vulnerability, and product use/promotion. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement

5. Enforcement Tools

A range of tools address non-compliance, used individually or combined. Details are available on the compliance actions and outcomes page. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement

6. Transparency and Reporting

TGA measures and reports performance for accountability. Published information includes enforcement outcomes, annual reports, and media releases. No comments are made on ongoing investigations unless in the public interest. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement

7. Related Resources

Key links include compliance principles for 2026-2027, education strategies, and specific guidance for areas like vaping, medicines, medical devices, and manufacturing. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-management-enforcement