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January 12, 2026
Approximately 5 minutes
Regulation Essentials for Therapeutic Goods in Australia – TGA Core Requirements
Regulation Essentials for Therapeutic Goods in Australia – TGA Core Requirements
Regulatory Framework and Authority
The Therapeutic Goods Administration (TGA), operating within the Australian Government Department of Health and Aged Care, administers the Therapeutic Goods Act 1989 and associated regulations. This legislation establishes a unified system to ensure therapeutic goods supplied in Australia are safe, effective, and of acceptable quality. The TGA evaluates products before market entry and monitors them post-market. Source: Regulation essentials - TGA
Categories of Therapeutic Goods
Therapeutic goods are divided into several regulated categories, each with specific requirements:
- Medicines: Prescription, over-the-counter, complementary (e.g., vitamins, herbal products)
- Medical Devices: From low-risk (Class I) to high-risk (Class III), including software and IVDs
- Biologicals: Human tissues, cells, blood/blood components, and biological medicines (e.g., vaccines, plasma derivatives)
- Blood and Blood Components: For transfusion or manufacturing
All must be entered in the Australian Register of Therapeutic Goods (ARTG) before supply, except for certain exemptions (e.g., personal importation limits).
Key Regulatory Requirements
Pre-Market Entry
- Registration/Listed/Inclusion: Higher-risk products (e.g., prescription medicines, Class III devices) require full registration with detailed evaluation; lower-risk (e.g., some complementary medicines, Class I devices) may be listed with self-assessed compliance.
- Conformity Assessment: Manufacturers must demonstrate compliance with relevant standards (e.g., Essential Principles for devices, GMP for manufacturing).
- Classification: Risk-based for devices (I to III) and IVDs (1 to 4), determining evidence and assessment level.
Manufacturing and Quality
- Compliance with Good Manufacturing Practice (GMP) or equivalent international standards is mandatory.
- TGA conducts inspections and accepts overseas GMP certifications under mutual recognition agreements.
Labelling, Packaging, and Advertising
- Strict rules ensure accurate information, risk communication, and prohibition of misleading claims.
- Advertising to consumers is restricted for certain products (e.g., prescription-only medicines).
Post-Market Monitoring
- Mandatory reporting of adverse events, recalls, and field safety corrective actions.
- Ongoing compliance monitoring, audits, and enforcement actions (including cancellations or suspensions of ARTG entries).
Special Access and Exemptions
- Special Access Scheme (SAS) and Authorised Prescriber (AP) schemes allow limited access to unapproved goods.
- Exemptions exist for personal use, clinical trials, and certain low-risk activities.
This risk-proportionate system aligns Australia with international standards while prioritizing public health protection. Detailed requirements for each category, ARTG application processes, GMP guidance, and advertising rules are outlined in the official TGA regulation essentials overview. Source: Regulation essentials - TGA
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