Legislation

The Australia New Zealand Food Standards Code – Standard 2.9.4 governs the formulation and labelling of Formulated Supplementary Sports Foods.

The Australian Immunisation Register Act 2015 establishes the Australian Immunisation Register, which is a national database that records vaccinations given to individuals.

The Gene Technology Act 2000 aims to provide a nationally consistent regulatory scheme for the safe use of GMOs.

The Gene Technology Regulations 2001 establish a national framework for the regulation of genetically modified organisms (GMOs) in Australia, ensuring safety and compliance in gene technology practices.

The Industrial Chemicals Act 2019 establishes a regulatory framework for the importation and manufacture of industrial chemicals in Australia.

The Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018 establishes the endotoxin limits for medical devices to minimise risks associated with endotoxin contaminants and residues.

The National Health and Medical Research Council Act 1992 establishes the NHMRC as a national body to promote health standards and foster medical research in Australia.

The Poisons Standard classifies medicines and poisons into different Schedules, signifying the degree of risk and the control recommended to be exercised over their availability to the public. Sometimes referred to as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

The Therapeutic Goods Act 1989 provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.

This Specification facilitates the release of de-identified adverse event report information recorded in the Adverse Event Management System (AEMS) portal to sponsors.

This Specification facilitates the release of specified kinds of therapeutic goods information relating to adverse events following immunisation to specified persons or bodies.

This Specification facilitates the publication of certain therapeutic goods information relating to complaints and investigations by the TGA in respect of the advertising of therapeutic goods and dissemination of generic information.

This Specification facilitates the public release of therapeutic goods information relating to advisory committee meetings.

This Specification facilitates the release of therapeutic goods information relating to advisory committee meetings to relevant persons or bodies for specified purposes.

The Act amends the Therapeutic Goods Act 1989 to improve regulation of therapeutic goods in Australia, enhancing safety and efficacy standards.

The Act amends the Therapeutic Goods Act 1989 to improve regulation of therapeutic goods in Australia, enhancing safety and efficacy standards.

This Act amends the Therapeutic Goods Act 1989 to improve regulation of therapeutic goods in Australia, enhancing safety and access.

This legislation aims to streamline and improve the regulation of therapeutic goods in Australia by updating parts of the Therapeutic Goods Act 1989.

The Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 introduces significant changes to enhance the regulation of therapeutic goods in Australia, focusing on safety, compliance, and innovation.

The Act amends the Therapeutic Goods Act 1989 to improve regulation of therapeutic goods in Australia, enhancing safety and efficacy standards.

This Act removed the Health Minister's approval requirement for RU486 (abortion medication), transferring decision-making authority to the Therapeutic Goods Administration.

This Instrument makes various amendments to the Therapeutic Goods Advertising Code.

This Instrument amends the Therapeutic Goods Advertising Code to add a reference to the Therapeutic Goods (Restricted Representations—HHD Group Pty Limited) (AZ) Permission 2021.

This Specification facilitates the release of specified therapeutic goods information relating to adverse events following immunisation to specified persons or bodies.

This Declaration amends the Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 to specify certain other therapeutic goods that are not medical devices for the purposes of the Therapeutic Goods Act 1989.