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| | Regulation of therapeutic goods - Wikipedia, the free encyclopedia |
 | | The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. | | | Therapeutic goods in Australia are regulated by the Therapeutic Goods Administration (TGA). | | | Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. |
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http://en.wikipedia.org/wiki/Regulation_of_therapeutic_goods
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| | Therapeutic Goods |
| | The objective of the TGC is to ensure responsible advertising in promoting the sale of therapeutic goods which may be purchased by the public without prescription and for which therapeutic claims are made. | | | Advertising for other therapeutic goods must comply with the provisions of the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990 and the industry’s Therapeutic Goods Advertising Code (TGAC) which can be downloaded from http://www.tgacc.com.au. | | | The Therapeutic Goods Code (TGC) was developed in 2000 in cooperation with several industry bodies and the Therapeutic Goods Authority. |
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http://www.afa.org.au/WebStreamer?page_id=936
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| | Regulation of therapeutic goods in Australia |
| | The objective of the Therapeutic Goods Act 1989, which came into effect on 15 February 1991, is to provide a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and ensure the quality, safety and performance of medical devices. | | | A 'therapeutic good' is broadly defined as a good which is represented in any way to be, or is likely to be taken to be, for therapeutic use (unless specifically excluded or included under Section 7 of the Therapeutic Goods Act 1989). | | | Medicines assessed as having a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy and are registered on the ARTG. |
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http://www.tga.gov.au/docs/html/tga/tgaginfo.htm
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| | Direct therapeutic exposure - encyclopedia article about Direct therapeutic exposure. |
| | Other techniques for treating PTSD include family therapy, psychodynamic psychotherapy, creative arts therapy, outward bound programs, and cognitive behavior therapy. | | | A similar therapy is Eye Movement Desensitization and Reprocessing (EMDR). | | | Boudewyns, P.A. & Hyer, L. "Physiological Response to Combat Memories and Preliminary Treatment Outcome in Vietnam Veteran PTSD patients treated with Direct Therapeutic Exposure." Behavior Therapy, 21, 63-87. |
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http://encyclopedia.thefreedictionary.com/Direct%20therapeutic%20exposure
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| | AAR: Publication: Recall: Trans-Tasman joint scheme for regulation of therapeutic products |
| | Therapeutic goods, including medicines and medical devices, are regulated under separate regimes by the Therapeutic Goods Administration (the TGA) in Australia and the Medicines and Medical Devices Safety Authority (Medsafe) in New Zealand. | | | The TGA is responsible for administering the Therapeutic Goods Act 1989 (Cth) (the TG Act), which provides a framework for the regulation of therapeutic goods in Australia. | | | Medsafe is responsible for regulating products used for a therapeutic purpose in New Zealand, and administers the Medicines Act 1981 (NZ) and parts of the Misuse of Drugs Act 1975 (NZ). |
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http://www.aar.com.au/pubs/prod/recall2apr04.htm
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| | Audit Report - Regulation of Non-prescription Medicinal Products |
| | The Therapeutic Goods Administration (TGA) is responsible for the regulation of the manufacture and supply of medicines, including complementary and over-the-counter medicines, in Australia, to protect public health and safety. | | | There are separate regulators for manufacturers of therapeutic goods; OTC medicines; and complementary medicines. | | | The audit did not examine the regulation of prescription medicines, devices, or other therapeutic goods. |
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http://www.anao.gov.au/WebSite.nsf/Publications/4BFF5A0954674D49CA256F6A008257DF
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| | Therapeutic Goods Amendment Bill (No. 2) 2002 (Bills Digest, no. 151, 2002-03) |
| | Under this definition, ‘therapeutic goods’ includes medicines, complementary medicines and therapeutic devices. | | | The offences for a breach of the therapeutic goods advertising requirements that apply to advertisements that do not require an approval are currently contained within the therapeutic goods regulations. | | | for therapeutic goods albeit medicines, complementary medicines or therapeutic devices are subject to a number of regulatory requirements including those contained within the TG Act, Therapeutic Goods Regulations (TG Regulations) and the Broadcasting Services Act 1992. |
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http://www.aph.gov.au/library/pubs/bd/2002-03/03bd151.htm
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| | DRUG FREE: Should the Government Regulate Vitamins and Herbs As Drugs? |
| | Amendment 401 to the Therapeutic Goods Regulation was gazetted on 18 December 1997 and specifically makes it illegal to make any representation that a therapeutic product is drug free. | | | Dr Susan Alder of the TGA was appointed as the Minister's delegate and in March 1997 responded that "by definition all therapeutic goods are drugs and therefore by legal definition the statement 'drug free' cannot be accurate if applied to a substance which is a therapeutic good." | | | The Industry proposed alternative is to develop a code of practice for the use of the words 'drug free' taking account of consumers' perception of the words 'drug free'. |
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http://www.iahf.com/asia/drugfree.html
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| | Audit Report - Drug Evaluation by the Therapeutic Goods Administration - Follow-up Audit |
| | Therapeutic Goods Administration, a Division of the Department of Health and Aged Care (DHAC), whose responsibilities include evaluating therapeutic drugs in accordance with the | | | The Department of Health and Aged Care implemented full-cost recovery for all operations within the scope of the Therapeutic Goods Act, including its drug evaluation activities, from the beginning of 1998–99. | | | The Department implemented full-cost recovery for all operations within the scope of the Therapeutic Goods Act, including its drug evaluation activities, from the beginning of 1998–99. |
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http://www.anao.gov.au/WebSite.nsf/Publications/4A256AE90015F69B4A25695400115A70
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| | Hot Topics |
| | This regulation was currently the responsibility of the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand. | | | The joint scheme will regulate medicines (including complementary medicines) and medical devices and is expected to come into force in July 2005, subject to the passage of legislation and ratification of the treaty. | | | Report to the Therapeutic Goods Administration on the rates of compliance of advertisements for therapeutic goods with the Therapeutic Goods Advertising Code (July 2004) |
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http://www.jtaproject.com/hot.htm
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| | Charter |
| | That the definition of Therapeutic use is an inappropriate and excessively prescriptive definition and as this treaty is predicated on regulations for therapeutic products and use, any such definition should be clear and concise and not encompass what would normally be items or practices of normal human interaction. | | | influencing, inhibiting or modifying a physiological process in humans; The simple act of laying on of hands in a Church or in some other place could be interpreted as a therapeutic use such as influencing, inhibiting or modifying a physiological process in humans and could be proscribed accordingly. | | | The New Zealand Charter of Health Practitioners Incorporated agree that the post-market monitoring of therapeutic products has previously been woefully inadequate as can be observed by the New Zealand Death statistics as set out in page 11. |
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http://www.healthcharter.org.nz/002.html
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| | ShareChat - Health - Therapeutic Products Agency - Regulatory Change |
| | The single bi-national agency will regulate medical devices and medicines in Australia and New Zealand and will give consumers in both countries full confidence that the medical devices and medicines they use will be safe, efficacious and of the highest quality. | | | This measure will enable the Department of Health and Ageing to provide the Australian Government with the best possible advice about public health needs to be met through the regulation of medical devices, medicines and other therapeutic goods. | | | A new Trans-Tasman Therapeutic Products Agency will be established in 2005 and will replace the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). |
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http://www.sharechat.co.nz/forum/showthread.php?t=42
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| | Therapeutic Goods Administration (TGA) |
| | Therapeutic Goods Administration oversees the regulation of therapeutic products and devices in Australia. |
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http://www.accc.gov.au/content/index.phtml/itemId/401353
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| | Milestones |
| | Joint (Aus/NZ) consultation paper released to stakeholder groups on a possible framework for a joint trans-Tasman agency to regulate therapeutic goods. | | | The following points reflect key decisions or actions to date in relation to formal cooperation between New Zealand and Australia in respect of the regulation of therapeutic goods: | | | Joint (Australia/New Zealand) Discussion Paper "A Proposal for a Trans-Tasman Therapeutic Agency to Regulate Therapeutic Products" released |
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http://www.jtaproject.com/milestones.htm
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| | Register of Surveys - Australian Market for In Vitro Diagnostic Devices (Survey of), Overview |
| | The regulation of therapeutic goods in Australia is subject to cost recovery, | | | to broaden the scope of IVD regulation in Australia to include all IVDs. | | | The regulation of therapeutic goods in Australia is subject to cost recovery, in that companies wishing to supply products pay fees and associated annual charges to have their applications reviewed and to maintain their products on the ARTG. |
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http://www.sch.abs.gov.au/SCH/A1610103.NSF/0/1FEAE42040306A17CA256CF5001DE23A
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| | Regulation of Medical Devices involving Software in Australia (ResearchIndex) |
| | Abstract: The Therapeutic Goods Administration (TGA) regulates the supply of therapeutic goods in Australia -- including medical devices. | | | an Overview John Jamieson Conformity Assessment Branch Therapeutic Goods... | | | Regulation of Medical Devices involving Software in Australia |
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http://citeseer.ist.psu.edu/534561.html
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| | Hawaiian Noni (spray) |
| | A therapeutic agent for a wide variety of conditions such as lack of energy, insomnia, arthritis, migraines, boosting the immune system, and more! | | | Noni has been used to help various conditions including allergies, cardiovascular problems, high/low blood pressure, arthritis, degenerative conditions, addictions, insomnia, strokes, obesity, kidney problems, diabetes, depression and much more. | | | J.B; Goldstein, S; Klein, J; and Pao, C.I. Regulation and action of insulin-like growth factors at the cellular level. |
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http://www.feel21.com/site/product.cfm?id=Hawaiian_Noni
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| | NZOOM - ONE News - National |
| | Australia and New Zealand have paved the way for the creation of a single trans-Tasman agency to oversee the regulation of drugs and other therapeutic goods. | | | The new agency will regulate prescription, over-the-counter and complementary medicines, as well as medical devices. | | | Australian parliamentary health secretary Trish Worth said the treaty represented an unprecedented level of trans-Tasman cooperation and collaboration. |
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http://onenews.nzoom.com/onenews_detail/0,1227,264562-1-7,00.html
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| | Internet Resource Guide: Health Law Resources |
| | Medicines regulation and the Therapeutic Goods Administration (Therapeutic Goods Administration) | | | Centre for Values, Ethics and the Law in Medicine | | | Complementary Medicines in the Australian Health System: Report to the Parliamentary Secretary to the Minister for Health and Ageing, September 2003 (Expert Committee on Complementary Medicines in the Health System). |
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http://www.aph.gov.au/library/intguide/law/healthlaw.htm
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| | The Institute for Research on Unlimited Love |
| | I believe that apology/forgiveness, as well as altruism have moral moorings, which means concern with seeking the good, and seek it in relation to others. | | | R.A. Emmons, “Gratitude is the Best Approach to Life” (Symposium entitled “Quest for the Good Life: Problems/Promises of Positive Psychology” at the Annual Convention of the American Psychological Association) Honolulu, HI, 28 July, 2004. | | | Dr. Levin is currently researching historical and theological perspectives on what it means to love and be loved by God, as well as the physical and mental health effects of such a loving relationship. |
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http://www.unlimitedloveinstitute.org/grant/index.html
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| | Therapeutic Goods Administration, Commonwealth of Australia - Australian Science at Work Corporate entry |
| | The objective of the Therapeutic Goods Act 1989, which came into effect on 15 February 1991, is to provide a national framework for the regulation of therapeutic goods in Australia and ensure their quality, safety and efficacy.' From http://www.health.gov.au/tga/docs/html/tga/tgaginfo.htm (5/12/00). | | | This was established in 1991 as a result of the Therapeutic Goods Act of 1989. | | | Here, the Committee formed part of the Therapeutic Goods Administration (TGA). |
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http://www.austehc.unimelb.edu.au/asaw/biogs/A000863b.htm
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| | Publication Details - AS 3848.1-1999 Filling of portable gas cylinders - Decant filling of medical air and oxygen into ... |
| | These gases are recognized as medicinal gases and as such are subject to regulation under the Therapeutic Goods Act 1989 (the Act) by the Therapeutic Goods Administration (TGA). | | | The requirements of this Act include entry of therapeutic goods (including medicinal gases) on the Australian Register for Therapeutic Goods and the licensing of manufacturers (as defined in the Act) by the TGA. | | | This Standard provides guidance on safe practices for the decant filling of medical air or medical oxygen into portable cylinders. |
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http://www.standards.com.au/catalogue/script/Details.asp?DocN=stds000023263
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| | GPR 169 |
| | The guidelines refer to reports on product recalls but urge that particular care be taken in relation to therapeutic products. | | | The Australian Press Council was requested by the Therapeutic Goods Administration Division of the Commonwealth Department of Health to give consideration to the manner in which news items are compiled by the press in relation to the recall of therapeutic goods. | | | The Council, when considering the request, found that one of its constituent bodies has established a set of guidelines which the Council recommends for general use. |
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http://www.presscouncil.org.au/pcsite/activities/guides/gpr169.html
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| | Interesting Web Sites |
| | Creative Therapeutics: Outstanding books by child psychiatrist Richard Gardner, M.D. Contraceptive Choices: Analysis by Robert A Hatcher, M.D., M.P.H. Drug Information: Database covering more than 7,000 prescription and nonprescription products [6/15/03] | | | Amazon Books: Internet's leading source of books, electronics, tools, toys, and many other consumer goods. | | | ConsumerLab.com: Evaluates the quality of dietary supplement and herbal products. |
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http://www.quackwatch.org/05Links/othersites.html
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| | Alert Digest No 9 of 2004 - Ministerial Correspondence |
| | The regulation orf therapeutic goods in Australia is a national scheme, in which health ministers of all jurisdictions have agreed to participate. | | | Regulations in place to adopt the Code in other States do not provide for disallowance of the Code at a State level. | | | I write in response to your query regarding clause 23 of this Bill (new sections 45 to 52 of the Therapeutic Goods (Victoria) Act 1994), permitting the making a code of practice and establishing the procedure for doing so. |
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http://www.parliament.vic.gov.au/sarc/2004alerts/04alt9min.htm
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| | TIAFTnet Observatory |
| | Journals for Latent Print and Fingerprint Examination - Chesapeake Bay Division - I. Journal of Pharmacology and Experimental Therapeutics Online | | | Publist (Find FREE information and publications from around the world) |
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http://www.tiaft.org/main/observatory.html
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| | Question for Oral Answer: Trans-Tasman Therapeutic Products Agency -Bilateral Treaty - Green Party |
| | I think the member may well even be pleased when she sees the extent of what has been considered in the joint regulator. | | | The Government has decided to include the regulation of complementary medicines and therapeutic dietary supplements in the proposed trans-Tasman therapeutic products agency. | | | Hon ANNETTE KING: Work undertaken by the New Zealand Institute of Economic Research suggests the costs of regulating complementary medicines within a joint agency would be significantly less than that of a New Zealand regulatory scheme. |
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http://www.greens.org.nz/searchdocs/other7094.html
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| | Joint Scheme for the Regulation of Therapeutic Products: Report of Health Committee - Green Party |
| | Basically, it will not matter what the Ministers say in their ministerial council, all the key powers will be delegated to a managing director who will be able to make rules without any recourse to our Parliament, but which will have an immediate effect in New Zealand. | | | It showed that dietary supplements would be classified and regulated under the same system as medicines and that the new agency would operate basically as an expanded version of the existing Australian therapeutic goods agency. | | | Joint Scheme for the Regulation of Therapeutic Products: Report of Health Committee |
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http://www.greens.org.nz/searchdocs/speech7878.html
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| | TSRI - News & Views |
| | Integrin's Regulation of Rac—Implications for Cancer and Cardiovascular Diseases (2/9/04) | | | TSRI Scientists Discover Therapeutic Strategy for "Misfolding Diseases" Analogous to Alzheimer's Disease (10/01/01) | | | Good Molecules Gone Bad: When Interferons Interfere with the Wrong Thing (3/07/05) |
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http://www.scripps.edu/newsandviews/e_archive.html
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| | KRC Israel |
| | Regulatory acts provide a national framework for the regulation of therapeutic goods in israel and ensure their quality, safety and efficacy. | | | According to publications of Israeli Ministry of Health local community expects that medicines and medical devices in the marketplace are safe and of high quality, to a standard at least equal to that of comparable countries. | | | KRC Inc. is prepared to provide it's services in Israel based on the local regulatory requirements. |
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http://www.kriger.com/israel2004/home_eng.html
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| | SourceTool.com - Home |
| | Sourcetool already lists more than 500,000 businesses that do business with other businesses. | | | SourceTool.com is the speediest, most relevant, most user-friendly free business to business search engine on the Internet. | | | It is the only business to business search engine whose Directory is based on the United Nations Standard Products and Services Code (UNSPSC), which provides the most efficient, flexible and accurate classification of goods and services available. |
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http://www.SourceTool.com
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