Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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317 result(s) found, displaying 176 to 200
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GuidanceGuidance for sponsors of faecal microbiota transplant (FMT) products, which are regulated as biologicals.
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GuidanceThis guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.
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GuidanceGuidance on the information that we include in AusPARS for prescription medicines and when we publish them.
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GuidanceGuidance for the deletion of commercially confidential and personal information in an Australian Public Assessment Report (AusPAR).
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GuidanceGuidance on declaring and managing conflicts of interest and confidentiality obligations for TGA advisory committee members.
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GuidanceAn overview on the application process for manufacturers aiming to obtain a TGA-issued Conformity Assessment certificate.
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GuidanceGuidance to explain what we need for software and apps that work with COVID-19 rapid antigen tests.
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GuidanceGuidance to help determine whether products are separate and distinct biologicals that will need to be included as separate ARTG entries.
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GuidanceGuidance for notifying the TGA about substantial changes to, or transfers of, Conformity Assessment certificates.
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GuidanceGuidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.
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GuidanceGuidance on applying for a provisional determination, which is the first step of the provisional approval pathway.
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GuidanceGuidance to help work out if your autologous HCT product is excluded from our regulation.
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GuidanceGuidance to help work out if your autologous HCT product is exempt from some aspects of our regulation.
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GuidanceThis guidance explains parts 2 and 3 of the Code, which requires advertising about therapeutic goods to be accurate, balanced, safe and not misleading.
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GuidanceRelease on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient. Access to the request form and instructions are within the guidance document.
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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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GuidanceThis guidance explains part 7 of the Code, which outlines rules for using samples and incentives when advertising therapeutic goods.
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GuidanceThis Guidance explains part 8 of the Code, which outlines rules for making restricted representations when advertising therapeutic goods.
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GuidanceGuidance to explain how the intended use of a biological product influences its classification and exemptions.
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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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GuidanceHow the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture of therapeutic goods.
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GuidanceGuidance on ARTG and Conformity Assessment requirements for immunohaematology reagents (IHRs).
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GuidanceGuidance on clinical performance requirements and risk mitigation strategies.
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GuidanceGuidance about the regulation of sport supplements in Australia for importers and sellers.
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GuidanceGuidance on how to request early scientific advice on a biowaiver justification.