Publication of regulatory compliance actions in Australia on the TGA web site

25 June 2013

Australia’s Therapeutic Goods Administration (TGA) has advised that, over the coming months, it will commence publishing information on specific compliance actions across all product types, as well as compliance actions relating to advertising and unlawful products.

This action is a result of the regulatory actions flowing from the TGA reforms: a blueprint for TGA's future which is the government’s response to the Transparency Review of the TGA. Recommendation 18 of the Transparency Review proposed that the TGA progressively develop and implement a system to publish the outcomes of investigations and compliance actions taken.

The TGA publically committed to providing more information about its compliance activities and as a result the TGA Regulatory Compliance Framework was created. The purpose of the Therapeutic Goods Administration’s (TGA) Regulatory Compliance Framework is to outline to stakeholders how the TGA manages its compliance function under its legislation. This Regulatory Compliance Framework sets out the TGA's overall approach to compliance and this framework will form the basis of new information to be published on the TGA web site.

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