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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)
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- Assessed listed medicines (23)
- Australian Register of Therapeutic Goods (ARTG) (26)
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- In Vitro Diagnostic medical devices (IVDs) (39)
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265 result(s) found, displaying 51 to 75
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GuidanceGuidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.
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GuidanceInformation to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.
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GuidanceThis guidance is for manufacturers of registered medicinal gases to understand our interpretation of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to GMP for medicinal products.
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GuidanceGuidance on using reports from COBs and submission requirements for evaluation of these applications.
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GuidanceThis guidance explains good manufacturing practice (GMP) requirements for Australian sponsors and manufacturers of medicines, active pharmaceutical ingredients (APIs) and sunscreens.
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GuidanceThis guidance outlines the information needed in your dossier for us to be able to effectively review your application for a biological therapeutic good.
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GuidanceGuidance for manufacturers outlining the procedures for submitting conformity assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)
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GuidanceClinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA's Good Clinical Practice (GCP) inspection program.
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GuidanceRequirements around the minimisation of transmission of communicable diseases for therapeutic goods containing biologicals and human cell or tissue (HCT).
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GuidanceGuidance on TGO 109: Standards for Biologicals - General and Specific Requirements.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance to help manufacturers of medical devices classify their devices correctly.
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GuidanceGuidance for supplying substitute medicines when registered medicines are unavailable or in short supply.
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GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
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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 clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.
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GuidanceAn overview of the Data Protection Scheme for assessed listed medicines, and the criteria that must be met for information to be considered protected under the Scheme.
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GuidanceGuidance on our approved terminology for medicines.
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GuidanceGuidance about the types of notifications and variations for biological medicines.
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GuidanceGuidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
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GuidanceGuidance on how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).
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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 for sponsors on the process for including IVD medical devices in the ARTG.
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GuidanceGuidance on the transitional arrangements and obligations of medical devices with a diagnostic function.