词条 | Therapeutic Goods Administration |
释义 |
| agency_name = Therapeutic Goods Administration | type = | nativename = | nativename_a = | nativename_r = | logo = Therapeutic Goods Administration logo.png | logo_width = | logo_caption = | picture = | picture_width = | picture_caption = | formed = 1989 | preceding1 = | preceding2 = | dissolved = | superseding = | jurisdiction = Commonwealth of Australia | headquarters = | coordinates = | motto = | employees = | budget = A$139 million (2015) | minister1_name = | minister1_pfo = | minister2_name = | minister2_pfo = | deputyminister1_name = | deputyminister1_pfo = | deputyminister2_name = | deputyminister2_pfo = | chief1_name = | chief1_position = | chief2_name = | chief2_position = | agency_type = | parent_department = Department of Health | parent_agency = | child1_agency = | child2_agency = | keydocument1 = | website = {{URL|http://www.TGA.gov.au/}} | footnotes = | map = | map_width = | map_caption = }} The Therapeutic Goods Administration (TGA) is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia.[1] It is a Division of the Australian Department of Health established under the Therapeutic Goods Act 1989 (Cth).[2][3] The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner. TGA Expert Advisory CommitteesThe TGA has nine statutory expert committees it may call upon to obtain independent advice on scientific and technical matters, including:
Trans-Tasman harmonisationThe governments of Australia and New Zealand were working towards establishing a Trans-Tasman joint agency for the regulation of drugs and therapeutic goods to replace the TGA and New Zealand's Medsafe. However, on 16 July 2007, the New Zealand State Services Minister Annette King announced that "The Government is not proceeding at this stage with legislation that would have enabled the establishment of a joint agency with Australia to regulate therapeutic products". She further advised that "The [New Zealand] Government does not have the numbers in Parliament to put in place a sensible, acceptable compromise that would satisfy all parties at this time. The Australian Government has been informed of the situation and agrees that suspending negotiations on the joint authority is a sensible course of action". Further details are available at the Australia New Zealand Therapeutic Products Authority (ANZTPA) website. See also
References1. ^{{cite web|url=http://www.tga.gov.au/about/|title=About the TGA|publisher=Department of Health Therapeutic Goods Administration}} 2. ^{{cite web|url=http://www.tga.gov.au/industry/legislation-about.htm#.Up2yD6r8nFA|title=About the Australian therapeutic goods legislation|publisher=Department of Health Therapeutic Goods Administration}} 3. ^Therapeutic Goods Act 1999 (Cth) External links
6 : Commonwealth Government agencies of Australia|Medical and health organisations based in Australia|National agencies for drug regulation|Regulation of medical devices|Life sciences industry|Regulatory authorities of Australia |
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