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.
We recently introduced new features to improve your experience using Guidance on our website.
Loading...
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
- (-) Complementary medicines (31)
- Advanced therapies (2)
- Advertising (35)
- Advisory bodies and committees (2)
- Artificial Intelligence (AI) (3)
- Assessed listed medicines (23)
- Australian Register of Therapeutic Goods (ARTG) (31)
- Biological medicines (22)
- Blood and blood components (10)
- Breast implant hub (1)
- Clinical trials (5)
- Cosmetics (4)
- COVID-19 (9)
- Disinfectants/Sterilants (5)
- Fees and payments (3)
- Import and export (8)
- In Vitro Diagnostic medical devices (IVDs) (41)
- Labelling and packaging (25)
- Legislation (8)
- Listed medicines (24)
- Manufacturing (40)
- Medical devices safety (24)
- Medicinal cannabis hub (4)
- Medicine safety (8)
- Metal-on-metal hip replacement implants hub (1)
- Non-prescription medicines (48)
- Over the counter (OTC) medicines (35)
- Prescription medicines (47)
- Registered complementary medicines (15)
- Regulatory compliance (27)
- Safety (15)
- Scheduling (national classification system) (5)
- Shortages (3)
- Sunscreens (1)
- TGA conformity assessment certification (7)
- Therapeutic goods regulation (30)
- Unique Device Identification (UDI) hub (2)
- Vaping hub (4)
- Weight loss products (1)
Search
31 result(s) found, displaying 1 to 25
-
GuidanceGuidance for sponsors and manufacturers to meet the technical, scientific and regulatory requirements to ensure the quality of probiotic medicine acceptable under the Therapeutic Goods Act 1989
-
GuidanceGuidance to help sponsors understand the potential overlap between certain foods, medicines, devices and cosmetics.
-
GuidanceGuidance on the regulatory requirements for assessed listed medicines.
-
GuidanceGuidance providing an overview of listed medicines and listed assessed medicines pathways and legislative requirements.
-
GuidanceGuidance about the administrative information to support assessed listed medicine applications.
-
GuidanceGuidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
-
GuidanceGuidance on the evaluation process and information required for new registered complementary medicines.
-
GuidanceGuidance for data requirements for microorganisms used as active ingredients in listed or registered complementary medicines. These are generally referred to as probiotics or postbiotics.
-
GuidanceGuidance on the format requirements for dossiers. Amendments to Part C to update the reference for dossier requirements for biologicals.
-
GuidanceGuidance on using reports from COBs and submission requirements for evaluation of these applications.
-
GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
-
GuidanceAn overview of the Data Protection Scheme for assessed listed medicines, and the criteria that must be met for information to be considered protected under the Scheme.
-
GuidanceGuidance on our approved terminology for medicines.
-
GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
-
GuidanceGuidance on the use of modified unprocessed herbal materials in complementary medicines
-
GuidanceGuidance explaining how the Comparable Overseas Bodies report-based process is associated with shortened evaluation timeframes for applications.
-
GuidanceInformation that must be submitted in order for an application to list an assessed listed medicine in the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceGuidance on complying with therapeutic goods advertising requirements.
-
GuidanceGuidance about the regulation of sport supplements in Australia for importers and sellers.
-
GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
-
GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
-
GuidanceGuidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.
-
GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
-
GuidanceGuidance for industry on how to apply for consent to supply therapeutic goods that do not comply with subsection 9(2) of TGO 92.
-
GuidanceGuidance on equivalence of herbal extracts in complementary medicines.