Guidance

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

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

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

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

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

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.

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.

Guidance to help manufacturers of medical devices classify their devices correctly.

Guidance on how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).

Guidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).

Guidance on good manufacturing practice (GMP) compliance requirements for domestic and overseas manufacturers of medicines and biologicals.

Guidance for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products.

Guidance to explain how the intended use of a biological product influences its classification and exemptions.

Guidance about the regulation of sport supplements in Australia for importers and sellers.

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

Guidance on medical device application processing timeframes.

This guidance helps sponsors and manufacturers of ‘unapproved’ therapeutic vapes understand quality and safety requirements, under the Therapeutic Goods (Medical Device Standard —Therapeutic Vaping Devices) Amendment Order 2024.

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

How to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.

This guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in TGO 105.