Guidance

Guidance on how medical devices must comply with the Essential Principles.

Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.

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.

Information about how Clinical Decision Support System (CDSS) software is regulated, including when they are and are not exempt from inclusion on the ARTG.

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).

Guidance for sponsors of medical devices seeking to include a medical device (including in vitro diagnostic devices) in the Australian Register of Therapeutic Goods (ARTG).

This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).

Find out how TGA regulates software and artificial intelligence (AI) based medical devices.

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

Guidance for healthcare facilities, including information about the requirements for data fields, timeframes for reporting and other considerations.

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 for what to do if the sponsor of a therapeutic good changes.

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.

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.