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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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Topic
- Advanced therapies (2)
- Advertising (33)
- Advisory bodies and committees (2)
- Artificial Intelligence (AI) (3)
- Assessed listed medicines (23)
- Australian Register of Therapeutic Goods (ARTG) (26)
- Biological medicines (21)
- Blood and blood components (10)
- Breast implant hub (1)
- Clinical trials (5)
- Complementary medicines (31)
- Cosmetics (4)
- COVID-19 (9)
- Disinfectants/Sterilants (5)
- Fees and payments (3)
- Import and export (8)
- In Vitro Diagnostic medical devices (IVDs) (39)
- Labelling and packaging (25)
- Legislation (8)
- Listed medicines (23)
- Manufacturing (40)
- Medical devices safety (24)
- Medicinal cannabis hub (4)
- Medicines safety (8)
- Metal-on-metal hip replacement implants hub (1)
- Non-prescription medicines (48)
- Over the counter (OTC) medicines (35)
- Prescription medicines (46)
- Registered complementary medicines (15)
- Regulatory compliance (25)
- Safety (15)
- Scheduling (national classification system) (4)
- Shortages (4)
- Software as a medical device (1)
- Sunscreens (1)
- TGA conformity assessment certification (7)
- Therapeutic goods regulation (29)
- Vaping hub (4)
- Weight loss products (1)
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265 result(s) found, displaying 101 to 125
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GuidanceThis OTC Medicine Monograph guidance outlines requirements for Australian market authorisation of oral medicines containing ranitidine hydrochloride as a single active ingredient when applied for as an OTC New Medicine N2 application.
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GuidanceGuidance on complying with therapeutic goods advertising requirements.
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GuidanceOTC medicine monograph: Topical imidazole antifungals for dermal use - clotrimazole and miconazole nitrate.
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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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GuidanceOTC medicine monograph guidance: paracetamol for oral use.
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GuidanceOTC medicine monograph guidance: Laxatives: Docusate sodium and/or sennosides.
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GuidanceThis OTC medicine monograph outlines the requirements for Australian market authorisation of oral medicines containing loperamide hydrochloride as a single active ingredient when applied for as 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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GuidanceOTC medicine monograph guidance.
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GuidanceGuidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).
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GuidanceThis OTC Medicine Monograph outlines the requirements for Australian market authorisation of a cough expectorant containing guaifenesin as a single active ingredient when applied for as an OTC new medicine N2 application.
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GuidanceGuidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.
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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 for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products.
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GuidanceGuidance applies to self-tests and point-of-care combo test kits.
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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 to assist Australian corporations seeking to apply for an Australian conformity assessment body (CAB) determination for medical devices (including IVDs) by the TGA.
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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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GuidanceGuidance for the deletion of commercially confidential and personal information in an Australian Public Assessment Report (AusPAR).
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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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GuidanceThis guidance is for all sponsors of products regulated as biologicals.