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.
- (-) In Vitro Diagnostic medical devices (IVDs) (41)
- (-) Prescription medicines (48)
- Advanced therapies (2)
- Advertising (33)
- Advisory bodies and committees (2)
- Artificial Intelligence (AI) (3)
- Assessed listed medicines (24)
- Australian Register of Therapeutic Goods (ARTG) (30)
- Biological medicines (22)
- Blood and blood components (10)
- Breast implant hub (1)
- Clinical trials (5)
- Complementary medicines (30)
- Cosmetics (4)
- COVID-19 (9)
- Disinfectants/Sterilants (5)
- Fees and payments (3)
- Import and export (8)
- Labelling and packaging (27)
- Legislation (8)
- Listed medicines (25)
- Manufacturing (40)
- Medical devices safety (24)
- Medicinal cannabis hub (4)
- Medicine safety (8)
- Metal-on-metal hip replacement implants hub (1)
- Non-prescription medicines (49)
- Over the counter (OTC) medicines (36)
- Registered complementary medicines (16)
- Regulatory compliance (27)
- Safety (15)
- Scheduling (national classification system) (5)
- Shortages (3)
- Sunscreens (2)
- TGA conformity assessment certification (7)
- Therapeutic goods regulation (32)
- Unique Device Identification (UDI) hub (2)
- Vaping hub (4)
- Weight loss products (1)
Search
87 result(s) found, displaying 1 to 25
-
GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
-
GuidanceTimeframes for supplying UDI compliant medical devices in Australia
-
GuidanceThis Guidance explains how overseas assessments can support our medical device certification and registration processes.
-
GuidanceThis guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
-
GuidanceGuidance for sponsors who have submitted applications for inclusion of medical devices including in-vitro diagnostics (IVDs), in the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceGuidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.
-
GuidanceGuidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.
-
GuidanceManufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
-
GuidanceGuidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
-
GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
-
GuidanceThis guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).
-
GuidanceGuidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).
-
GuidanceGuidance to assist sponsors to understand the process for submitting a priority registration application.
-
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 on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.
-
GuidanceGuidance on when and how to provide Product Information to us.
-
GuidanceGuidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.
-
GuidanceGuidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines
-
GuidanceGuidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).
-
GuidanceThis guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.
-
GuidanceGuidance on provisional registration process for prescription medicines with provisional determination.
-
GuidanceGuidance for preparing a technical file review, as part of your application to include an in-vitro medical device in the Australian Register of Therapeutic Goods.
-
GuidanceClassifying in-vitro diagnostic medical devices (IVDs) according to the health risk that may arise from an incorrect result.
-
GuidanceGuidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.
-
GuidanceGuidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.