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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)
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- In Vitro Diagnostic medical devices (IVDs) (39)
- Labelling and packaging (25)
- Legislation (8)
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- Manufacturing (40)
- Medical devices safety (24)
- Medicinal cannabis hub (4)
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- Metal-on-metal hip replacement implants hub (1)
- Non-prescription medicines (48)
- Over the counter (OTC) medicines (35)
- Prescription medicines (46)
- Registered complementary medicines (15)
- Regulatory compliance (25)
- Safety (15)
- Scheduling (national classification system) (4)
- Shortages (4)
- Software as a medical device (1)
- Sunscreens (1)
- TGA conformity assessment certification (7)
- Therapeutic goods regulation (29)
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265 result(s) found, displaying 1 to 25
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GuidanceGuidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92
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GuidanceGuidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.
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GuidanceGuidance to help sponsors understand the potential overlap between certain foods, medicines, devices and cosmetics.
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GuidanceGuidance on dossier information required for registered complementary medicine applications, to be consistent with the Common Technical Document (CTD) format.
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GuidanceGuidance on the regulatory requirements for assessed listed medicines.
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GuidanceGuidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.
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GuidanceGuidance providing an overview of listed medicines and listed assessed medicines pathways and legislative requirements.
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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 explaining the regulatory requirements for listed medicines and how we undertake compliance reviews.
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GuidanceThese requirements apply to applications for the addition of new ingredients, or variation of existing ingredients, as listed in the Permissible Ingredients Determination, that are lodged with the TGA from 1 February 2023.
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GuidanceGuidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.
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GuidanceGuidance about the administrative information to support assessed listed medicine applications.
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GuidanceThe requirements for an effective OTC medicines application commences 1 March 2016.
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GuidanceAdministrative information to support OTC medicine applications in Australia
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GuidanceDetailed guidance for exempt Clinical Decision Support Software (CDSS) which complements the general guidance already published.
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GuidanceGuidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
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GuidanceManufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
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GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
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GuidanceGuidelines for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
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GuidanceAssists in the interpretation of the PIC/S GMP requirements when manufacturing compounded medicines
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.
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GuidanceGuidance on how to provide the required patient information materials with all implantable and active implantable medical devices.
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GuidanceGuidance on submitting an effective prescription medicines application.
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GuidanceThis guidance document provides information about when and how clinical decision support software is regulated in Australia by the TGA.