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Program implementation guide for TGA staff
TGA reforms: A blueprint for TGA's future
15 March 2013
Version 2.0, February 2013
|Version||Description of change||Author||Effective date|
|V1.0||Original Publication||Office of Program Management||September 2012|
|V2.0||Updated Publication to reflect minor changes in the allocation of project responsibilities, and to conform to accessibility guidelines. Added RSG 3 Project||Office of Program Management||February 2013|
About the Therapeutic Goods Administration
- The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
- The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.
- The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
- The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.
- To report a problem with a medicine or medical device, please see the information on Reporting problems on the TGA website.