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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- 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 (26)
- 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)
- Prescription medicines (47)
- Registered complementary medicines (15)
- Regulatory compliance (27)
- Safety (15)
- Scheduling (national classification system) (5)
- Shortages (3)
- Sunscreens (1)
- TGA conformity assessment certification (7)
- Therapeutic goods regulation (30)
- Unique Device Identification (UDI) hub (2)
- Vaping hub (4)
- Weight loss products (1)
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278 result(s) found, displaying 251 to 275
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GuidanceGuidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations.
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GuidanceGuidance about when information released to the public about therapeutic goods is considered advertising.
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GuidanceUnderstanding the requirements of Section 11 of the Therapeutic Goods Advertising Code.
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GuidanceGuidance on the mandatory reporting scheme for medicine shortages and permanent discontinuations, and our approach to compliance.
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GuidanceThis guidance is for sponsors intending to use the priority review pathway for biologicals.
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GuidanceGuidance to help sponsors understand the process of submitting a priority inclusion application.
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GuidanceGuidance explaining sponsor requirements for IVD conformity assessment through manufacturer agreements and regulatory compliance.
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GuidanceGuidance on the stages of preparing and submitting an application for inclusion of a Class 2, 3 or 4 biological in the ARTG.
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GuidanceAn outline of the regulatory process and a summary of the requirements to successfully submit a biologicals application.
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GuidanceGuidance for providing acceptable evidence to support indications and claims made about your listed medicine.
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GuidanceThis guidance explains part 6 of the Code, which outlines requirements for using endorsements and testimonials in advertisements about therapeutic goods.
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GuidanceGuidance on the process and regulatory requirements to register prescription medicines.
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GuidanceGuidance about evidence required to substantiate the quality of the product, for over-the-counter (OTC) medicine registration applications.
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GuidanceThis guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes.
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GuidanceTips for sponsors, distributors and retailers on creating prescription medicine labels that are compliant with Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91).
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GuidanceGuidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
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GuidanceGuidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed medicines.
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GuidanceGuidance for what to do if the sponsor of a therapeutic good changes.
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GuidanceGuidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.
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GuidanceGuidance for applicants on information required for Module 1 in dossiers for applications for registered complementary medicines to be consistent with the Common Technical Document (CTD) format
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GuidanceInformation required to establish quality for listed medicines
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GuidanceGuidance on how the Poisons Standard is amended and the processes that underpin scheduling policy
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GuidanceRisk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form.
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GuidanceGuidance to help you understand the different types of complementary medicines.
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GuidanceFor applications lodged from March 2018.