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)
- Advertising (13)
- Assessed listed medicines (3)
- Australian Register of Therapeutic Goods (ARTG) (9)
- Biological medicines (20)
- Blood and blood components (9)
- Clinical trials (3)
- Complementary medicines (2)
- Cosmetics (1)
- Fees and payments (2)
- Import and export (2)
- In Vitro Diagnostic medical devices (IVDs) (1)
- Labelling and packaging (3)
- Legislation (1)
- Listed medicines (5)
- Manufacturing (9)
- Medical devices safety (1)
- Medicine safety (1)
- Non-prescription medicines (4)
- Over the counter (OTC) medicines (4)
- Prescription medicines (9)
- Registered complementary medicines (4)
- Regulatory compliance (5)
- Safety (4)
- Scheduling (national classification system) (1)
- Shortages (1)
- Therapeutic goods regulation (6)
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60 result(s) found, displaying 1 to 25
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GuidanceGuidance on GCP inspections for clinical trial sites of investigational biologicals, medicines and medical devices regulated under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes.
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GuidanceGuidance to help you understand requirements for disease information and advertising.
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GuidanceGuidance on bioavailability and/or bioequivalence aspects of prescription medicines including information on biowaivers.
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GuidanceGuidance on providing adventitious agent safety information in applications for medicines containing, or manufactured using, materials of animal or human origin.
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GuidanceAustralian recommendations and requirements
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GuidanceGuidance on the format requirements for dossiers. Amendments to Part C to update the reference for dossier requirements for biologicals.
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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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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 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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GuidanceGuidance about the types of notifications and variations for biological medicines.
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GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
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GuidanceThis guidance will help you understand our pharmacovigilance inspection program (PVIP).
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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 for manufacturers in the development of Technical Master Files (TMF) relevant to blood, blood components and haematopoietic progenitor cells.
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GuidanceGuidance about how to advertise therapeutic goods exclusively to health professionals.
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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 on good manufacturing practice (GMP) compliance requirements for domestic and overseas manufacturers of medicines and biologicals.
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GuidanceGuidance for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products.
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GuidanceGuidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
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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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GuidanceThis guidance is for all sponsors of products regulated as biologicals.