Regulation and Policy

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.

Visit the TGA website for an introduction to supplying therapeutic goods in Australia, and to access list of Regulatory Affairs consultants to help with your regulatory requirements.

Australian regulatory requirements for therapeutic goods

The TGA oversees the two schemes under which clinical trials involving unapproved therapeutic goods may be conducted, the Clinical Trial Notification (CTN) Scheme and the Clinical Trial Exemption (CTX) Scheme. Visit the website for a step-by-step guide to the application process, including a schedule of fees and charges.

TGA Business Services allows industry to manage some therapeutic good registration applications, view and cancel their current entries on the Australian Register of Therapeutic Goods (ARTG), and much more. The TGA has also created the SME Assist Hub, which is designed to help small and medium enterprises, and R&D groups developing new medicines and medical devices (including apps) understand their regulatory and legislative obligations with targeted tools and content.

The Office of the Gene Technology Regulator has been established within the Australian Government Department of Health to provide administrative support to the Gene Technology Regulator in the performance of the functions under the Gene Technology Act 2000.

Australian regulatory requirements for medical devices

The Therapeutic Goods Administration (TGA) in collaboration with the medical devices industry sector has developed a consolidated reference document detailing the Australian regulatory requirements for medical devices.

This document - which is currently under review - has been developed as a guide to assist sponsors and manufacturers understand the regulatory requirements for medical devices in Australia. The information in this document replaces many of the existing guidance documents and information sheets for medical devices that were on the TGA website.

Pharmaceutical Benefits Advisory Committee

The Pharmaceutical Benefits Advisory Committee (PBAC) is established under the National Health Act 1953 (the Act). Its primary role is to recommend to the Minister for Health which medicines and medicinal preparations should be subsidised by the Australian Government under the Pharmaceutical Benefits Scheme (PBS). In doing this, PBAC considers both the effectiveness and cost of the proposed medicines and medicinal preparations. View the full guidelines and details about how to make a submission.

Medical Services Advisory Committee

The Medical Services Advisory Committee (MSAC) is an independent expert committee that provides advice to the Federal and State Ministers for Health on the strength of the evidence relating to the comparative safety, clinical effectiveness and cost-effectiveness of any new or existing medical service or technology. The Committee also takes into account the circumstances under which public funding should be supported through listing on the Medicare Benefits Schedule (MBS).