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Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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- Advanced therapies (2)
- Advertising (33)
- Advisory bodies and committees (2)
- Artificial Intelligence (AI) (3)
- Assessed listed medicines (23)
- Australian Register of Therapeutic Goods (ARTG) (26)
- Biological medicines (21)
- Blood and blood components (10)
- Breast implant hub (1)
- Clinical trials (5)
- Complementary medicines (31)
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- Fees and payments (3)
- Import and export (8)
- In Vitro Diagnostic medical devices (IVDs) (39)
- Labelling and packaging (25)
- Legislation (8)
- Listed medicines (23)
- Manufacturing (40)
- Medical devices safety (24)
- Medicinal cannabis hub (4)
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- Non-prescription medicines (48)
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- Regulatory compliance (25)
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- Software as a medical device (1)
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- Therapeutic goods regulation (29)
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265 result(s) found, displaying 201 to 225
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GuidanceGuidance for sponsors on how and when to use a boxed warning in PI or a CMI.
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GuidanceGuidance for sponsors and manufacturers about regulatory requirements for exempt therapeutic goods.
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GuidanceGuidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
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GuidanceThis guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybin from 1 July 2023.
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GuidanceGuidance on how to meet regulatory requirements for the manufacture and supply of tampons in Australia.
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GuidanceAustralian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.
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GuidanceGuidance for industry on how to apply for consent to supply therapeutic goods that do not comply with subsection 9(2) of TGO 92.
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GuidanceGuidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).
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GuidanceGuidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.
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GuidanceGuidance on the requirements that specifically apply to active medical devices.
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GuidanceGuidance for manufacturers to assist them with managing 3-D printing risks and meeting the Australian regulatory requirements for medical devices.
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GuidanceThis guidance assists providers of IV drips to understand how to comply with the therapeutic goods advertising requirements in Australia.
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GuidanceGuidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.
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GuidanceGuidance for importation, supply and wholesale requirements for medicinal cannabis.
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GuidanceGuidance clarifying the interaction between our requirements and AHPRA advertising guidelines.
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GuidanceGuidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
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GuidanceThis guidance aims to help advertisers apply the legislative requirements for advertising therapeutic goods on social media platforms.
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GuidanceGuidance on advertising services that involve therapeutic goods.
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GuidanceGuidance on understanding the rules for advertising therapeutic goods to consumers
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GuidanceGuidance for sponsors of certain medical devices who are required to submit annual reports.
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GuidanceGuidance on reporting adverse events for sponsors of medical devices.
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GuidanceGuidance about how to promote your business and service, without advertising biologicals to the public.
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GuidanceGuidance on preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).
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Applying for a Class 1 biological to be added in the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for preparing and submitting an application for inclusion of a Class 1 biological on the ARTG. -
GuidanceFind out how TGA regulates software and artificial intelligence (AI) based medical devices.