Guidance

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.

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

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 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 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

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

This guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.

Guidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.

Guidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.

Guidance on the regulatory requirements for assessed listed medicines.

Guidance on dossier information required for registered complementary medicine applications, to be consistent with the Common Technical Document (CTD) format.

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

Guidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.

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

Guidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.

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