Guidance

Guidance about how Clinical Decision Support System (CDSS) software is regulated. Find out when this software is exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG).

This guidance explains how sponsors and manufacturers should prepare and maintain a Technical Master File (TMF) for blood, blood components, and haematopoietic progenitor cells. It outlines TMF requirements, submission processes, evaluation pathways and change management requirements.

This guidance explains how sponsors should prepare, submit and maintain a Type II Plasma Master File (PMF), for export only therapeutic goods that contain or are produced from human blood or plasma.

This guidance explains how sponsors should prepare, submit and maintain a Type I Plasma Master File (PMF) for therapeutic goods for supply in Australia that contain or are produced from human blood or plasma.

This guidance explains the regulatory requirements for supplying therapeutic goods that contain, or are produced from, human plasma.

This guidance is for journalists and news organisations and explains when news reports about therapeutic goods may be regulated as advertising.

Guidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.

This guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.

Guidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.

Manufacturers are responsible for maintaining evidence that their devices comply with the Essential Principles.

Guidance on when a manufacturing licence is required for bacteriophage therapy products and how a time-limited Goods Manufacturing Practice exemption will apply. Understand your regulatory obligations when producing bacteriophage products in Australia.

Guidance on the legislative framework that applies to manufacturing, advertising and supplying compounded medicines.

Australian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.

Guidance on when a manufacturing licence is required for manufacturing medicinal maggots and how a time-limited Goods Manufacturing Practice (GMP) exemption applies. Understand your regulatory obligations when producing medicinal maggot products in Australia.

Guidance applies to self-tests and point-of-care combo test kits.

Guidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.

Guidance on clinical performance and risk mitigation requirements for self‑test IVDs for chlamydia, gonorrhoea and syphilis.

Guidance providing an overview of the legislative framework for listed medicines and assessed listed medicines.

This guidance is to assist sponsors in fulfilling the regulatory obligations necessary to ensure that any representations made about their listed medicine(s) comply with the requirements of the Therapeutic Goods Act 1989.

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

This Guidance explains part 9 of the Code, which has requirements about advertising the price of prescription medicines and certain pharmacist-only medicines to the public.

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

This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biological

Learn how to determine whether your product is a cosmetic or therapeutic good and understand the regulatory and advertising requirements that apply.

Guidance on regulatory requirements for Ahpra-registered dental practitioners making and adapting personalised medical devices for patients.