Guidance

Guidance for manufacturers and sponsors (including health professionals) on how we define and regulate custom-made medical devices (CMMDs).

Guidance 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.

Guidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.

Provides Guidance on the regulatory requirements for labels and other medicine presentation.

Guidance 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

This Guidance describe the requirements and standards for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia

This guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.

Guidance on the regulatory requirements for assessed listed medicines.

Guidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.

Guidance providing an overview of listed medicines and listed assessed medicines pathways and legislative requirements.

Guidance explaining the post-market surveillance of listed medicines and how we undertake compliance reviews.

Assists in the interpretation of the PIC/S GMP requirements when manufacturing compounded medicines

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.

Guidance 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).

Guidance on the evaluation process and information required for new registered complementary medicines.

Guidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).

Guidance for data requirements for microorganisms used as active ingredients in listed or registered complementary medicines. These are generally referred to as probiotics or postbiotics.

Guidance on the regulation of system or procedure packs and using the special conformity assessment procedure.

Guidance to change an ARTG registered over-the-counter (OTC) medicine.

Guidance for manufacturers outlining the procedures for submitting conformity assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)

This 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.

Information to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.

This guidance explains good manufacturing practice (GMP) requirements for Australian sponsors and manufacturers of medicines, active pharmaceutical ingredients (APIs) and sunscreens.

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.