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)
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277 result(s) found, displaying 126 to 150
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GuidanceGuidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.
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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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GuidanceThis guidance is for all sponsors of products regulated as biologicals.
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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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GuidanceThis guidance will assist you in determining if a product is a cosmetic or a therapeutic good and how to comply with Australian regulatory requirements and advertising rules for therapeutic goods.
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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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GuidanceMandatory labelling requirements for biologicals and human cell and tissue materials.
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GuidanceGuidance for notifying the TGA about substantial changes to, or transfers of, conformity assessment certificates.
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GuidanceInformation for manufacturers, sponsors and health professionals on the definition of a custom-made medical device and how we regulate them.
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GuidanceThis guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.
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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 explain how the intended use of a biological product influences its classification and exemptions.
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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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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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GuidanceThis Guidance explains part 9 of the Code, which has requirements about advertising the price of prescription medicines and certain pharmacist-only medicines to the public.
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GuidanceGuidance to help work out if your autologous HCT product is excluded from our regulation.
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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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GuidanceGuidance about the regulation of sport supplements in Australia for importers and sellers.