We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
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.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
Topic
- (-) Manufacturing (41)
- Advertising (32)
- Breast implant hub (1)
- Clinical trials (5)
- Committees and advisory bodies (2)
- Compliance and enforcement (30)
- Cosmetics (4)
- COVID-19 (11)
- Fees and payments (3)
- Import and export (9)
- Labelling and packaging (26)
- Legislation (9)
- Medicinal cannabis hub (4)
- Metal-on-metal hip replacement implants hub (1)
- Safety monitoring and information (46)
- Scheduling (national classification system) (6)
- Shortages and supply disruptions (3)
- Sunscreens (2)
- Unique Device Identification (UDI) hub (2)
- Vaping hub (5)
- Weight loss products (1)
Search
61 result(s) found, displaying 1 to 25
-
GuidanceFind out how TGA regulates software and artificial intelligence (AI) based medical devices.
-
GuidanceThis guidance explains good manufacturing practice (GMP) requirements for Australian sponsors and manufacturers of medicines, active pharmaceutical ingredients (APIs) and sunscreens.
-
GuidanceGuidance for manufacturers to help you manage risks and meet regulatory requirements.
-
GuidanceGuidance for manufacturers and sponsors (including health professionals) on how we define and regulate custom-made medical devices (CMMDs).
-
GuidanceGuidance for manufacturers and sponsors of personalised medical devices, including health professionals. Learn what we mean by ‘specified articles’ and the difference between exempt vs excluded products.
-
GuidanceProvides guidance on the regulatory requirements for labels and other medicine presentation.
-
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
-
GuidanceThis guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
-
GuidanceGuidance on the regulatory requirements for assessed listed medicines.
-
GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.
-
GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.
-
GuidanceAssists in the interpretation of the PIC/S GMP requirements when manufacturing compounded medicines
-
GuidanceGuidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion on the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceGuidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).
-
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 regulation of system or procedure packs and using the special conformity assessment procedure.
-
GuidanceThis guidance is for manufacturers of registered medicinal gases to understand our interpretation of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to GMP for medicinal products.
-
GuidanceGuidance for manufacturers outlining the procedures for submitting conformity assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)
-
GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
-
GuidanceGuidance to help manufacturers of medical devices classify their devices correctly.
-
GuidanceGuidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
-
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 how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).
-
GuidanceThis guidance explains requirements for registering a non-prescription OTC medicine on the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceGuidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).