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Abstract

The article discusses the history of medicine regulation in Australia and describes the evolution of the Australian regulatory system, noting this process of evolving has been the key to the success of the Australian Therapeutic Goods Administration (TGA) in protecting the public health. Future challenges facing regulators are discussed and the TGA's strategic plans to address these are referenced.

Keywords

Therapeutic Goods Administration TGA Office of Prescription Medicines Australia Medicine regulation Australian Drug Evaluation Committee ADEC Adverse Drug Reactions Advisory Committee ADRAC Clinical trials Pharmacovigilance

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The Australian Medicines Regulatory System: A Risk-Based Approach to Regulation

Abstract

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