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

被引:0
|
作者
Rohan Hammett
Leonie Hunt
机构
[1] Therapeutic Goods Administration,Office of Prescription Medicines
关键词
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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学科分类号
摘要
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.
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页码:17 / 20
页数:3
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