Program implementation guide for TGA staff

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TGA reforms: A blueprint for TGA's future

15 March 2013

Version 2.0, February 2013

Version history

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.

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