Guidance

Guidance to help sponsors determine if their therapeutic goods are medicines, biologicals, or medical devices.

Guidance providing an overview of the regulation of listed medicines and registered complementary medicines in Australia.

Guidance on complying with the Essential Principles for medical devices in Australia, including safety and performance requirements, risk management, design, and evidence needed for ARTG inclusion.

Guidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.

This guidance aims to help advertisers understand the legislative requirements for advertising therapeutic goods on social media platforms.

This guidance outlines pharmacists’ regulatory responsibilities when supplying therapeutic vapes to support patients in quitting smoking or managing nicotine dependence.

Guidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.

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

This guidance is for sponsors of applications for inclusion of medical devices, including in vitro diagnostic (IVD) devices, in the Australian Register of Therapeutic Goods (ARTG).

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

Guidance for manufacturers to help you manage risks and meet regulatory requirements.

This guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.

Guidance to help sponsors comply with changes to the Permissible Ingredients Determination.

Guidance on how to meet regulatory requirements for the manufacture and supply of tampons in Australia.

Guidance on GCP inspections for clinical trial sites of investigational biologicals, medicines and medical devices regulated under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes.

Learn how to change the sponsor of a therapeutic good in Australia, including requirements, process steps, and regulatory obligations for sponsors and manufacturers.

Guidance about how to advertise therapeutic goods exclusively to health professionals.

Guidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing.

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 to help you understand requirements for disease information and advertising.

This guidance explains the new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances effective from 1 July 2024. It helps sponsors interpret the new classification rule, conformity assessment requirements and transition arrangements.

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