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 (22)
- Blood and blood components (10)
- Breast implant hub (1)
- Clinical trials (5)
- Complementary medicines (32)
- 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 (24)
- Manufacturing (41)
- Medical devices safety (24)
- Medicinal cannabis hub (4)
- Medicines safety (8)
- Metal-on-metal hip replacement implants hub (1)
- Non-prescription medicines (49)
- Over the counter (OTC) medicines (35)
- Prescription medicines (47)
- Registered complementary medicines (15)
- Regulatory compliance (26)
- 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
267 result(s) found, displaying 1 to 25
-
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 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 and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92
-
GuidanceGuidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.
-
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 on dossier information required for registered complementary medicine applications, to be consistent with the Common Technical Document (CTD) format.
-
GuidanceGuidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.
-
GuidanceAdministrative information to support OTC medicine applications in Australia
-
GuidanceThese requirements apply to applications for the addition of new ingredients, or variation of existing ingredients, as listed in the Permissible Ingredients Determination, that are lodged with the TGA from 1 February 2023.
-
GuidanceGuidance about the administrative information to support assessed listed medicine applications.
-
GuidanceGuidance providing an overview of listed medicines and listed assessed medicines pathways and legislative requirements.
-
GuidanceThe requirements for an effective OTC medicines application commences 1 March 2016.
-
GuidanceGuidance explaining the regulatory requirements for listed medicines and how we undertake compliance reviews.
-
GuidanceGuidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.
-
GuidanceGuidance to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices.
-
GuidanceGuidelines for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.
-
GuidanceManufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
-
GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
-
GuidanceGuidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.
-
GuidanceDetailed guidance for exempt Clinical Decision Support Software (CDSS) which complements the general guidance already published.
-
GuidanceAssists in the interpretation of the PIC/S GMP requirements when manufacturing compounded medicines
-
GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.