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Topic: Regulation of therapeutic goods

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	Regulation of therapeutic goods - Wikipedia, the free encyclopedia
		Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation.
		Therapeutic goods in Australia are regulated by the Therapeutic Goods Act (TGA).
		Therapeutic goods in the United States are regulated by the Food and Drug Administration (FDA).
	en.wikipedia.org /wiki/Regulation_of_therapeutic_goods (698 words)

	Medical Devices
		The Therapeutic Goods Administration (TGA), a Division of the Commonwealth Department of Health and Ageing, is responsible for administering the Therapeutic Goods Act 1989.
		Under the legislation some therapeutic goods have been specifically excluded from entry in the ARTG while others may be given specific approval for a special purpose without being entered in the Register.
		Therapeutic goods, which are currently registered or listed in the Register, cannot be transferred to the new part.
	www.moit.gov.il /NR/exeres/B0302E53-90B5-4DFB-AE53-4E4D4342830B.htm (3990 words)

	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.
		The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing and is responsible for administering the provisions of the legislation.
		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).
	www.tga.gov.au /docs/html/tga/tgaginfo.htm (696 words)

	Therapeutic Goods (Site not responding. Last check: 2007-10-29)
		Therapeutic Goods which are available only from a pharmacist or a medical or dental practitioner, including prescription only medicines, may not be advertised to the general public.
		The Therapeutic Goods Code (TGC) was developed in 2000 in cooperation with several industry bodies and the Therapeutic Goods Authority.
		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.
	www.afa.org.au /public/content/ViewCategory.aspx?id=507 (193 words)

	ALERT DIGEST 14 of 1994 - 5
		Victoria, as a member of the National Co-ordinating Committee on Therapeutic Goods which deals with all therapeutic goods in general, is committed to the control of hawking and of supply by vending machines of therapeutic goods.
		The National Co-ordinating Committee on Therapeutic Goods is to meet in November to attempt to reach consensus on the types of exemption orders to be used to exempt condoms in each of the States and Territories.
		The Therapeutic Goods Administration does not receive individual patient data that is in the name of the subject, a code may be used; thus the individual's privacy is protected.
	www.parliament.vic.gov.au /sarc/94alerts/alert14e.htm (2669 words)

	Regional Harmonisation (Site not responding. Last check: 2007-10-29)
		The Regulators' Forum was designed to develop a regional approach and understanding and to foster closer collaboration in the Asia Pacific region between the regulatory authorities.
		The Forum was co-chaired by the Therapeutic Goods Administration and the Pharmaceutical and Food Safety Bureau of Japan, and was held in conjunction with the World Self-Medication Industry (WSMI) 5th Asia Pacific Regional Conference.
		The Forum followed on from the success of the Regulators' Forum held in Sydney in 2000, with a continuation of a strong cooperative and collaborative approach amongst the therapeutic goods Asia Pacific regional regulators in sharing experiences on the regulation of non-prescription medicines.
	www.jtaproject.com /regional.htm (342 words)

	Analysis of the MACCAH Draft: Regulation of CAM
		Effective regulation of the complementary and alternative health sector serves the public interest by protecting consumers from unsafe or inadequately trained practitioners, and from products that are unsafe or make misleading claims.
		Such regulation is also expected to encompass traditional practitioners who use acupuncture or herbalism as part of their practice (eg, practitioners of Ayurvedic and traditional Chinese medicine).
		Regulation of TCM is currently being phased in under the TCM Practitioners Act 2000.
	www.quackwatch.org /07PoliticalActivities/MACCAH/1-1.html (3665 words)

	Therapeutic Goods Regs (Am)
		"(iv) goods for use in the diagnosis of hepatitis C virus; or".
		Part 3 of the Act applies to those goods as if subregulations 10.5, 11.2 and 11.4 of these Regulations had not commenced until the application is decided.
		Part 3 of the Act applies to those goods as if subregulations 10.3, 11.5 and 11.8 of these Regulations had not commenced until the application is decided.
	frli.law.gov.au /s97.vts?VdkVgwKey=1996B00422&ViewTemplate=frliview.hts&action=View (3011 words)

	Functional foods
		Regulation of so-called functional foods under a separate standard would be likely to mislead the public into believing the functional foods were more nutritious, or more desirable in general.
		It would then be up to the manufacturer to decide whether to seek registration as a therapeutic good.
		After a period of usage as a therapeutic good (presumably, several years), the question of whether the product could be regarded as a food could be reviewed.
	members.optusnet.com.au /~polsoc/ppas_fd1.htm (900 words)

	Outcome 1: Population Health and Safety
		During 1999-2000, regulation of therapeutic goods will continue to be managed cohesively and strategically with a focus on public health and safety.
		Regulation of therapeutic goods and chemicals contributes to the protection and promotion of the health of Australians.
		Other priorities include: regulating the siting, construction, commissioning and operation of the proposed replacement research reactor; promotion of uniformity in radiation protection law in Australia; the clean-up of Maralinga; participation in the Comprehensive Test Ban Treaty; and informing and educating in relation to the safe use of medical radiation and UV and other non-ionising radiation.
	www.health.gov.au /internet/wcms/Publishing.nsf/e11ffa331b366c54ca2569210006982f/health-pubs-budget99-pbs-partc_1.htm (6680 words)

	Regulation of therapeutic goods - Enpsychlopedia
		Therapeutic goods in Australia are regulated by the Therapeutic Goods Administration (TGA).
		Therapeutic goods in the Brazil are regulated by the Brazilian Health Ministry.
		The availability of drugs is regulated by classification by the Medicines Control Agency as part of marketing authorisation of a product.
	www.psychcentral.com /psypsych/Regulation_of_therapeutic_goods (376 words)

	Alert Digest No 9 of 2004 - Ministerial Correspondence (Site not responding. Last check: 2007-10-29)
		The regulation orf therapeutic goods in Australia is a national scheme, in which health ministers of all jurisdictions have agreed to participate.
		Disallowance at a State level is not in the spirit of the national scheme and would detract from the achievement of its objectives.
		Regulations in place to adopt the Code in other States do not provide for disallowance of the Code at a State level.
	www.parliament.vic.gov.au /sarc/2004alerts/04alt9min.htm (827 words)

	POISONS AND THERAPEUTIC GOODS REGULATION 2002
		Labelling of unscheduled therapeutic substances PART 7 - ANALYSIS AND DISPOSAL OF SEIZED GOODS Division 1 - Analysis of seized goods 143.
		Storage of and interference with seized goods 149.
		Modification of applied provisions of Commonwealth therapeutic goods laws with respect to advertising: section 31 (3) PART 9 - MISCELLANEOUS 171.
	www.austlii.edu.au /au/legis/nsw/consol_reg/patgr2002398 (1258 words)

	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.
		This issue is not one of public safety, it is clearly a market choice issue and therefore is covered by either the Trade Practices Act or the Therapeutic Goods Act both of which prevent false and misleading claims.
		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."
	www.iahf.com /asia/drugfree.html (1005 words)

	Complementary and Alternative Medicine Regulation in New Zealand
		Currently, there is no specific legislation to regulate CAM practitioners, with the exception of chiropractors who are regulated by the Chiropractors Act 1982.
		The proposals for a joint trans-Tasman agency to regulate therapeutic products are described in a recent consultation paper[i].
		While the other CAM modalities are not regulated by statute, voluntary self-regulation protocols have been put in place by some professional organisations that represent CAM practitioners.
	www.newhealth.govt.nz /maccah/regulation.htm (970 words)

	Submission to Senate Inquiry into the Tobacco Industry - 1994.
		The war was so terrible that it was thought good to give the men some pleasure before they went 'over the top', often to their deaths.
		Quite apart from the abhorrence of a government tacitly agreeing to kill its citizens to save a few dollars, the fact that the companies make this submission suggests that they are well aware of the effect of their products, and culpable accordingly.
		Regulations can then be made quickly and expeditiously based on the latest research to reduce consumption.
	www.nsma.org.au /sub94.htm (7334 words)

	11
		The fees and charges for the revised regulatory program, detailed in schedule 5 of the Therapeutic Goods (Medical Devices) Regulations 2002, is summarised in a document available from the TGA web site at http://www.tga.gov.au/devices/devices.htm.
		The arrangements are dependent on whether the patients are classified as Category A, as defined in the Regulations.
		The duty rate for consumables tends to be around 5% plus 10% Goods and Services Tax, while medical equipment generally enters duty and GST free (although there are some exceptions).
	www.israeltrade.org.au /medicaldevices.html (5441 words)

	Therapeutic Goods Administration, Commonwealth of Australia - Australian Science at Work Corporate entry
		In 1991 the Proprietary Medicines Advisory Committee's functions were transferred from the Victorian Government to the Federal Government.
		This was established in 1991 as a result of the Therapeutic Goods Act of 1989.
		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).
	www.austehc.unimelb.edu.au /asaw/biogs/A000863b.htm (225 words)

	The Green Light - Health Fraud (50-100)
		The NSW Public Health Bulletin is produced by the Public Health Division of the NSW Department of Health as an information vehicle for the whole public health community in New South Wales (Australia).
		Regulation of advertising of therapeutic goods in Australia
		In Australia all advertisements and generic information provided about Therapeutic Goods directed to the public must comply with provisions of the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990 and the Therapeutic Goods Advertising Code (TGAC).
	www.ratbags.com /rsoles/gl/health2.htm (1304 words)

	[No title]
		In fact supplements in Australia are regulated and classed as therapeutic goods under the Therapeutic Goods Act.
		However, there is no evidence the TGA regulates supplements as drugs, only therapeutic goods.
		Finally, An important quote from the TGA; “The current Australian regulatory framework for complementary medicines under Therapeutic goods Act 1989 is not subject to the standards and guidelines of the CODEX Commission.
	www.evehillary.org /reply.mp.template.doc (551 words)

	Natural Herbal Remedies at The Herbalist - Home Page
		The Herb Research Foundation is the world's first and foremost source of accurate, science-based information on the health benefits and safety of herbs---and expertise in sustainable botanical resource development.
		In Australia all advertisements and generic information published about therapeutic goods directed to consumers must comply with special legal requirements.
		ESCOP was founded in June 1989 as an umbrella organisation representing national phytotherapy associations across Europe, especially in their discussions with European medicines regulators.
	www.theherbalist-shop.com /links.htm (446 words)

	Government encourages moves to establish a joint therapeutic goods agency for Australia and New Zealand (Site not responding. Last check: 2007-10-29)
		The Federal Government has agreed in principle to establish a joint regulator for therapeutic goods in Australia and New Zealand, the Parliamentary Secretary to the Minister for Health and Aged Care, Senator Grant Tambling, announced today.
		This regulation was currently the responsibility of the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand.
		Senator Tambling said work on a trans-Tasman regulator built on gains from other significant Government activities, including developments in global harmonisation of regulatory arrangements for medical devices and good manufacturing practice and closer cooperation with the European Union, as well as within the region.
	www.tgamedsafe.org /media/010705aus.htm (433 words)

	GUIDE TO NSW OHS LEGISLATION - OHSIM - The University of Sydney
		Employees are also required to cooperate with their employer and other people to enable compliance with the Act or regulations (Section 20).
		This is the Occupational Health and Safety Regulation 2001.
		This chapter is the foundation of the Regulation.
	www.usyd.edu.au /ohs/ohs_manual/legislation.shtml (1395 words)

	Milestones (Site not responding. Last check: 2007-10-29)
		Australian Government agreed in principle to the establishment of a joint trans-Tasman agency to regulate therapeutic goods.
		New Zealand Cabinet agreed in principle to the establishment of a joint trans-Tasman agency to regulate therapeutic goods.
		The Health Ministers, with their Trade and Commerce Minister colleagues, agreed that a project to explore the viability of establishing a joint trans-Tasman therapeutics regulator should be given priority on the TTMRA work programme.
	www.jtaproject.com /milestones.htm (276 words)

	Dietitians Association of Australia (DAA) : Info for Professionals : DAA Submissions : November 2001 - April 2001
		The Dietitians Association of Australia (DAA) supports the proposal to consolidate the regulatory arrangements for therapeutic goods, services for gene technology and chemical safety evaluation into one statutory authority.
		DAA also recognises that a future integration of the regulation of therapeutic goods and foods might be of value.
		As there is an increasing number of functional foods in the marketplace there is the potential for inconsistencies in the regulations that are developed, particularly in the area of claims made for products.
	www.daa.asn.au /index.asp?PageID=2145835899 (508 words)

	New to this sector
		Due to the special nature of healthcare products, care is taken in the categorisation and assessment of any product intended to be marketed for human therapeutic use.
		There are various curbs on advertising of therapeutic goods to protect the consumer and create a fair marketplace.
		Compared to the controls on advertising of most fast moving consumer goods, advertising of therapeutic goods can seem complex.
	www.asmi.com.au /new_to_this_sector.htm (540 words)

	UTS: Environment, Health and Safety Branch
		There is a large number of standards, codes of practice, acts and regulations to keep track of when managing a laboratory.
		If these quantities are exceeded a flammable goods cabinet is needed.
		Laminar-flow cabinets and biological-safety cabinets shall be used in accordance with AS 2252, parts 1 and 2 and AS 2647.
	www.ehs.uts.edu.au /hazards/generallabsafety.html (745 words)

	Concord International Health Food Webpage
		If Ganoderma is taken simultaneously with other Western medication it will complement and enhance their therapeutic properties, and at the same time minimise their side effect on the human body.
		The legendary effect of Ganoderma is on promoting general good health and vitality.
		There has been keen interest in the field of biomedical technology concerning the therapeutic effects of Germanium.
	www.concordhealth.net /e_sunchih.htm (1399 words)

	Australian Physician Disciplined for Misrepresenting Mannatech Products to Patients
		In assessing the level of risk, factors such as the strength of a product, side effects, potential harm through prolonged use, toxicity and the seriousness of the medical condition for which the product is intended to be used, are all taken into account.
		The aim of licensing and standards is to protect public health by ensuring that medicines and medical devices meet definable standards of quality assurance and are manufactured in conditions that are clean and free of contaminants.
		Thus, under the definitions provided by the Therapeutic Goods Administration, it is my opinion that these products marketed by Mannatech do not contain any therapeutic good which could help in preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury.
	www.rickross.com /reference/mannatech/mannatech1.html (5538 words)

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