Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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309 result(s) found, displaying 126 to 150
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GuidanceGuidance explaining how the Comparable Overseas Bodies report-based process is associated with shortened evaluation timeframes for applications.
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GuidanceGuidance explaining how the method of preparation influences classification and whether autologous HCTs are eligible for exemptions.
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GuidanceGuidance for biological sponsors on the eligibility criteria and supporting documents required for priority determination applications
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GuidanceGuidance on submitting the CPD for prescription medicines.
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GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.
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GuidanceGuidance and examples to help you understand the regulatory framework for personalised medical devices.
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GuidanceGuidance on requirements for Australian market authorisation of tablets containing aspirin, for an OTC new medicine N2 application.
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GuidanceGuidance on complying with therapeutic goods advertising requirements.
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GuidanceGuidance on requirements for Australian market authorisation of topical imidazole antifungal medicines for dermal use, containing clotrimazole or miconazole nitrate, for an OTC New Medicine N2 application.
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GuidanceGuidance for sponsors on the information required to establish quality for listed medicines.
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GuidanceGuidance on requirements for Australian market authorisation of oral medicines containing loperamide hydrochloride, for an OTC New Medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of oral medicines containing paracetamol, for an OTC New Medicine N2 application.
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GuidanceGuidance on requirements for Australian market authorisation of oral laxative medicines containing docusate sodium and/or sennosides, for an OTC new medicine N2 application.
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GuidanceGuidance for sunscreen manufacturers who must comply with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-13).
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GuidanceGuidance on good manufacturing practice (GMP) compliance requirements for domestic and overseas manufacturers of medicines and biologicals.
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GuidanceGuidance for sponsors or suppliers of biologicals in Australia on their ongoing responsibilities after a product is included on the Australian Register. of Therapeutic Goods (ARTG).
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GuidanceGuidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
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GuidanceGuidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).
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GuidanceGuidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93.
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GuidanceGuidance applies to self-tests and point-of-care combo test kits.
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GuidanceGuidance for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products.
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GuidanceGuidance on requirements for Australian market authorisation of a cough expectorant containing guaifenesin, for an OTC new medicine N2 application.
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GuidanceGuidance for sponsors of faecal microbiota transplant (FMT) products, which are regulated as biologicals.
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GuidanceGuidance about the process of applying for a priority determination, which is the first step of the priority review registration pathway.
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GuidanceGuidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.