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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 statutory framework set out in the Act is supplemented by the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. The central mechanism through which therapeutic goods (being medicines, biologicals and medical devices) are regulated is the Australian Register of Therapeutic Goods ( ARTG ).
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
The Australia New Zealand Therapeutic Products Authority (ANZTPA) is a proposed authority which if adopted in both Australia and New Zealand will be the sole authority which regulates therapeutic goods in both countries. The authority will replace the Therapeutic Goods Administration in Australia [1] and Medsafe in New Zealand. [2]
In Western Australia, supply of certain S3 preparations listed in Appendix J of the Poisons Regulations 1965 (WA) are recordable under Regulation 35A. As of 2006, Appendix J products specified are: hydrocortisone, hydrocortisone acetate, pseudoephedrine, and nicotine preparations were included in Schedule 3.
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 ...
Pages in category "Medical regulation in Australia" The following 4 pages are in this category, out of 4 total. This list may not reflect recent changes. A.
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia; Australia New Zealand Therapeutic Products Authority; Australian Drug Evaluation Committee; Australian Technical Advisory Group on Immunisation