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The Australian Prudential Regulation Authority (APRA) is a statutory authority of the Australian Government and the prudential regulator of the Australian financial services industry. APRA was established on 1 July 1998 in response to the recommendations of the Wallis Inquiry.
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. [4] As part of the Department of Health and Aged Care, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods).
The Australian Health Practitioner Regulation Agency (AHPRA), infrequently spelt as the Australian Health Practitioners Regulation Agency, [3] is a statutory authority founded in 2010 which is responsible, in collaboration with the Medical Board of Australia, for registration and accreditation of health professionals as set out in the Australian legislation called the National Registration and ...
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A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD). In April 2013, MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used for ...
In a recent paper published in Nature Medicine, researchers found that 43% of FDA-approved AI medical devices lacked any clinical validation data. And, out of 521 AI devices the researchers ...
The ACCC administers the Competition and Consumer Act, and has standing to take action in the Federal Court of Australia to enforce its provision. [8] The Competition and Consumer Act contains a broad range of provisions, such as provisions on anti-competitive conduct, the Australian Consumer Law and regulation of telecommunications and energy industries. [9]
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