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
- (-) Labelling and packaging (26)
- (-) 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)
- 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
65 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 of personalised medical devices, including health professionals. Learn what we mean by ‘specified articles’ and the difference between exempt vs excluded products.
-
GuidanceGuidance for manufacturers and sponsors (including health professionals) on how we define and regulate custom-made medical devices (CMMDs).
-
GuidanceGuidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
-
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 to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.
-
GuidanceThis guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.
-
GuidanceGuidance on the regulatory requirements for assessed listed medicines.
-
GuidanceGuidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.
-
GuidanceAssists in the interpretation of the PIC/S GMP requirements when manufacturing compounded medicines
-
GuidanceGuidance on how to provide the required patient information materials with all implantable and active implantable medical devices.
-
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 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 on how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).
-
GuidanceGuidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).
-
GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.