The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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- (-) Therapeutic goods regulation (30)
- Advanced therapies (2)
- Advertising (35)
- Advisory bodies and committees (2)
- Artificial Intelligence (AI) (3)
- Assessed listed medicines (23)
- Australian Register of Therapeutic Goods (ARTG) (31)
- Biological medicines (22)
- Blood and blood components (10)
- Breast implant hub (1)
- Clinical trials (5)
- Complementary medicines (31)
- Cosmetics (4)
- COVID-19 (9)
- Disinfectants/Sterilants (5)
- Fees and payments (3)
- Import and export (8)
- In Vitro Diagnostic medical devices (IVDs) (41)
- Labelling and packaging (25)
- Legislation (8)
- Listed medicines (24)
- Manufacturing (40)
- Medical devices safety (24)
- Medicinal cannabis hub (4)
- Medicine safety (8)
- Metal-on-metal hip replacement implants hub (1)
- Non-prescription medicines (48)
- Over the counter (OTC) medicines (35)
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- Registered complementary medicines (15)
- Regulatory compliance (27)
- Safety (15)
- Scheduling (national classification system) (5)
- Shortages (3)
- Sunscreens (1)
- TGA conformity assessment certification (7)
- Unique Device Identification (UDI) hub (2)
- Vaping hub (4)
- Weight loss products (1)
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30 result(s) found, displaying 1 to 25
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GuidanceGuidance for sponsors who have submitted applications for inclusion of medical devices including in-vitro diagnostics (IVDs), in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices.
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GuidanceGuidance to help manufacturers of medical devices classify their devices correctly.
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GuidanceThis guidance will assist companies making announcements, to comply with their continuous disclosure obligations, without advertising therapeutic goods to the public.
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GuidanceGuidance on the transitional arrangements and obligations of medical devices with a diagnostic function.
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GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.
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GuidanceGuidance on complying with therapeutic goods advertising requirements.
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GuidanceGuidance and examples to help you understand the regulatory framework for personalised medical devices.
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GuidanceGuidance on good manufacturing practice (GMP) compliance requirements for domestic and overseas manufacturers of medicines and biologicals.
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GuidanceGuidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).
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GuidanceGuidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
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GuidanceThis guidance will assist you in determining if a product is a cosmetic or a therapeutic good and how to comply with Australian regulatory requirements and advertising rules for therapeutic goods.
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GuidanceGuidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.
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GuidanceGuidance about the regulation of sport supplements in Australia for importers and sellers.
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GuidanceGuidance on how we make use of assessments from comparable overseas regulators (CORs).
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GuidanceThis guidance is to assist health practitioners understand their requirements when prescribing ‘unapproved’ therapeutic goods for an individual patient using the Special Access Scheme (SAS).
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GuidanceGuidance detailing self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.
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GuidanceHow to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.
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GuidanceGuidance to help you understand which therapeutic goods will be regulated as a biological.
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GuidanceGuidance for sponsors and manufacturers about medical device definitions and requirements for system or procedure packs.
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GuidanceThis guidance applies to manufacturers of medical devices that are regulated as system or procedure packs and supplied using the special conformity assessment procedure regulatory pathway.
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GuidanceGuidance on how to meet regulatory requirements for the manufacture and supply of tampons in Australia.
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GuidanceGuidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
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GuidanceGuidance for sponsors of antibiotics on collecting and providing pre- and post-market information about antibiotic resistance.
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GuidanceGuidance on advertising services that involve therapeutic goods.