We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. 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.
Let us know what you think about these changes by completing our short survey. Your feedback will help us to continue improving our Guidance content.
Use the filters below to narrow your search.
Filter results
You can narrow down the results using the filters.
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)
Results for
"[search-keyword]"
Search
265 result(s) found, displaying 126 to 150
-
GuidanceThis guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.
-
GuidanceGuidance on declaring and managing conflicts of interest and confidentiality obligations for TGA advisory committee members.
-
GuidanceAn overview on the application process for manufacturers aiming to obtain a TGA-issued conformity assessment certificate.
-
GuidanceGuidance to explain what we need for software and apps that work with COVID-19 rapid antigen tests.
-
GuidanceGuidance to help determine whether products are separate and distinct biologicals that will need to be included as separate ARTG entries.
-
GuidanceThis guidance will assist you in determining if a product is a cosmetic or a therapeutic good and how to comply with Australian regulatory requirements and advertising rules for therapeutic goods.
-
GuidanceMandatory labelling requirements for biologicals and human cell and tissue materials.
-
GuidanceGuidance for notifying the TGA about substantial changes to, or transfers of, conformity assessment certificates.
-
GuidanceThis guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.
-
GuidanceInformation for manufacturers, sponsors and health professionals on the definition of a custom-made medical device and how we regulate them.
-
GuidanceGuidance on applying for a provisional determination, which is the first step of the provisional approval pathway.
-
GuidanceThis guidance explains part 7 of the Code, which outlines rules for using samples and incentives when advertising therapeutic goods.
-
GuidanceThis Guidance explains part 8 of the Code, which outlines rules for making restricted representations when advertising therapeutic goods.
-
GuidanceThis Guidance explains part 9 of the Code, which has requirements about advertising the price of prescription medicines and certain pharmacist-only medicines to the public.
-
GuidanceGuidance to explain how the intended use of a biological product influences its classification and exemptions.
-
GuidanceGuidance to help work out if your autologous HCT product is excluded from our regulation.
-
GuidanceGuidance to help work out if your autologous HCT product is exempt from some aspects of our regulation.
-
GuidanceRelease on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient. Access to the request form and instructions are within the guidance document.
-
GuidanceThis guidance explains parts 2 and 3 of the Code, which requires advertising about therapeutic goods to be accurate, balanced, safe and not misleading.
-
GuidanceGuidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.
-
GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
-
GuidanceGuidance about the regulation of sport supplements in Australia for importers and sellers.
-
GuidanceGuidance on how to request early scientific advice on a biowaiver justification.
-
GuidanceHow the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture of therapeutic goods.
-
GuidanceGuidance on clinical performance requirements and risk mitigation strategies.