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Regulation Of Therapeutic Goods
The regulation of THERAPEUTIC GOODS, that is 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 is the case in Australia
Australia
. The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be marketed. There is usually some degree of restriction of the availability of certain therapeutic goods depending on their risk to consumers
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Anti-convulsant
ANTICONVULSANTS (also commonly known as ANTIEPILEPTIC DRUGS or as ANTISEIZURE DRUGS) are a diverse group of pharmacological agents used in the treatment of epileptic seizures . Anticonvulsants are also increasingly being used in the treatment of bipolar disorder and borderline personality disorder , since many seem to act as mood stabilizers , and for the treatment of neuropathic pain . Anticonvulsants suppress the excessive rapid firing of neurons during seizures. Anticonvulsants also prevent the spread of the seizure within the brain. Conventional antiepileptic drugs may block sodium channels or enhance γ-aminobutyric acid (GABA ) function. Several antiepileptic drugs have multiple or uncertain mechanisms of action. Next to the voltage-gated sodium channels and components of the GABA system, their targets include GABAA receptors, the GAT-1 GABA transporter, and GABA transaminase . Additional targets include voltage-gated calcium channels , SV2A , and α2δ
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Sedatives
A SEDATIVE or TRANQUILLISER is a substance that induces sedation by reducing irritability or excitement . At higher doses it may result in slurred speech, staggering gait , poor judgment, and slow, uncertain reflexes . Doses of sedatives such as benzodiazepines , when used as a hypnotic to induce sleep , tend to be higher than amounts used to relieve anxiety, whereas only low doses are needed to provide a peaceful effect. Sedatives can be misused to produce an overly-calming effect (alcohol being the classic and most common sedating drug). In the event of an overdose or if combined with another sedative, many of these drugs can cause unconsciousness (see hypnotic ) and even death
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Benzodiazepines
BENZODIAZEPINES (BZD, BZS), sometimes called "BENZOS", are a class of psychoactive drugs whose core chemical structure is the fusion of a benzene ring and a diazepine ring. The first such drug, chlordiazepoxide (Librium), was discovered accidentally by Leo Sternbach in 1955, and made available in 1960 by Hoffmann–La Roche , which, since 1963, has also marketed the benzodiazepine diazepam (Valium). In 1977 benzodiazepines were globally the most prescribed medications. They are in the family of drugs commonly known as minor tranquilizers . Benzodiazepines enhance the effect of the neurotransmitter gamma-aminobutyric acid (GABA) at the GABAA receptor
GABAA receptor
, resulting in sedative , hypnotic (sleep-inducing ), anxiolytic (anti-anxiety), anticonvulsant , and muscle relaxant properties. High doses of many shorter-acting benzodiazepines may also cause anterograde amnesia and dissociation
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Anti-depressant
ANTIDEPRESSANTS are drugs used for the treatment of major depressive disorder and other conditions, including dysthymia , anxiety disorders , obsessive compulsive disorder , eating disorders , chronic pain , neuropathic pain and, in some cases, dysmenorrhoea , snoring, migraine , attention-deficit hyperactivity disorder (ADHD), addiction , dependence , and sleep disorders . They may be prescribed alone or in combination with other medications. The most important classes of antidepressants are the selective serotonin reuptake inhibitors (SSRIs), serotonin–norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), reversible inhibitors of monoamine oxidase A (RIMAs), tetracyclic antidepressants (TeCAs), and noradrenergic and specific serotonergic antidepressant (NaSSAs). St John\'s wort is also used in the treatment of depression
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Anti-inflammatory
ANTI-INFLAMMATORY or ANTIINFLAMMATORY refers to the property of a substance or treatment that reduces inflammation or swelling . Anti-inflammatory drugs make up about half of analgesics , remedying pain by reducing inflammation as opposed to opioids , which affect the central nervous system to block pain signaling to the brain. CONTENTS* 1 Nonsteroidal anti-inflammatory drugs * 1.1 Side effects * 1.2 Antileukotrines * 1.3 Immune selective anti-inflammatory derivatives (ImSAIDs) * 2 Bioactive compounds * 3 Long-term effects * 4 Ice
Ice
treatment * 5 Health supplements * 6 Anti-inflammatory foods * 6.1 Measurement of dietary inflammation * 7 Exercise * 8 Interactions with NSAIDs * 9 References NONSTEROIDAL ANTI-INFLAMMATORY DRUGSNonsteroidal anti-inflammatory drugs (NSAIDs) alleviate pain by counteracting the cyclooxygenase (COX) enzyme
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Vitamin
A VITAMIN is an organic compound and a vital nutrient that an organism requires in limited amounts. An organic chemical compound (or related set of compounds) is called a vitamin when the organism cannot synthesize the compound in sufficient quantities, and it must be obtained through the diet; thus, the term vitamin is conditional upon the circumstances and the particular organism. For example, ascorbic acid (one form of vitamin C ) is a vitamin for humans, but not for most other animal organisms. Supplementation is important for the treatment of certain health problems, but there is little evidence of nutritional benefit when used by otherwise healthy people. By convention the term vitamin does not include other essential nutrients , such as dietary minerals , essential fatty acids , essential amino acids (which are needed in greater amounts than vitamins) or the many other nutrients that promote health, and are required less often to maintain the health of the organism
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Antibiotics
ANTIBIOTICS (From ancient Greek αντιβιοτικά, antiviotika) also called ANTIBACTERIALS, are a type of antimicrobial drug used in the treatment and prevention of bacterial infections . They may either kill or inhibit the growth of bacteria . A limited number of antibiotics also possess antiprotozoal activity. Antibiotics
Antibiotics
are not effective against viruses such as the common cold or influenza ; drugs which inhibit viruses are termed antiviral drugs or antivirals rather than antibiotics. Sometimes the term antibiotic (which means "opposing life") is used to refer to any substance used against microbes , synonymous with antimicrobial. Some sources distinguish between antibacterial and antibiotic; antibacterials are used in soaps and disinfectants , while antibiotics are used as medicine. Antibiotics
Antibiotics
revolutionized medicine in the 20th century
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Food And Drug Act
The FOOD AND DRUGS ACT (formal title "An Act respecting food, drugs, cosmetics and therapeutic devices") is an act of the Parliament of Canada regarding the production, import , export , transport across provinces and sale of food , drugs , contraceptive devices and cosmetics (including personal cleaning products such as soap and toothpaste ). It was first passed in 1920 and most recently revised in 1985. It attempts to ensure that these products are safe, that their ingredients are disclosed and that drugs are effective and are not sold as food or cosmetics. It also states that cures for disease listed in Schedule A (including cancer , obesity , anxiety , asthma , depression , appendicitis , and sexually transmitted diseases ), cannot be advertised to the general public
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Food And Drug Administration (Burma)
The DEPARTMENT OF FOOD AND DRUG ADMINISTRATION (Burmese : အစားအသောက်နှင့် ဆေးဝါးကွပ်ကဲရေး ဦးစီးဌာန; abbreviated FDA) is Burma's food safety regulatory body, which oversees the safety and quality of food, drugs, medical devices and cosmetics. FDA was established in 1995. The agency was established under the 1992 National Drug Law, which also established the Food and Drug Board of Authority , which regulates and controls the manufacture, import, export, storage, distribution and sale of food and drugs, in the interests of public safety. SEE ALSO * Ministry of Health (Burma) REFERENCES * ^ A B "Food and Drug Control Activity" (PDF). Health in Myanmar 2012. Ministry of Health. 2012. Retrieved 6 July 2015. * ^ "The National Drug Law" (PDF). The State Law and Order Restoration Council. 30 October 1992
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Raw Material
A RAW MATERIAL, also known as a FEEDSTOCK or most correctly UNPROCESSED MATERIAL, is a basic material that is used to produce goods, finished products, energy, or intermediate materials which are feedstock for future finished products. As feedstock, the term connotes these materials are bottleneck assets and are highly important with regard to producing other products. An example of this is crude oil , which is a raw material and a feedstock used in the production of industrial chemicals , fuels , plastics , and pharmaceutical goods; lumber is a raw material used to produce a variety of products including furniture. The term "raw material" denotes materials in minimally processed or unprocessed in states; e.g., raw latex , crude oil, cotton, coal , raw biomass , iron ore , air , logs , or seawater i.e
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United Kingdom
The UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND, commonly known as the UNITED KINGDOM (UK) or BRITAIN, is a sovereign country in western Europe. Lying off the north-western coast of the European mainland , the UK includes the island of Great Britain
Great Britain
, the north-eastern part of the island of Ireland
Ireland
and many smaller islands. Northern Ireland
Northern Ireland
is the only part of the United Kingdom
United Kingdom
that shares a land border with another sovereign state‍—‌the Republic of Ireland
Ireland
. Apart from this land border, the UK is surrounded by the Atlantic Ocean, with the North Sea
North Sea
to its east, the English Channel
English Channel
to its south and the Celtic Sea to its south-south-west, giving it the 12th-longest coastline in the world
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Controlled Drug In United Kingdom
The United Kingdom Misuse of Drugs Act 1971 aimed to control the possession and supply of numerous listed drugs and drug-like substances as a controlled substance . The act allowed and regulated the use of some CONTROLLED DRUGS (designated CD) by various classes of persons (e.g. doctors) acting in their professional capacity. In clinical practice, this mostly applies to the use of strong opiates for pain management and some amphetamine -like stimulants used for Attention-deficit hyperactivity disorder ; both of which are regulated under Schedule 2. The Royal Pharmaceutical Society maintains a live database of the legal classification of medicines. CONTENTS* 1 Schedules * 1.1 Schedule 1 - CD Lic * 1.2 Schedule 2 - CD * 1.3 Schedule 3 - CD No Reg * 1.4 Schedule 4 * 1.5 Schedule 5 - CD Inv P e.g. cannabis and LSD except when licensed by the Home Office to carry out research
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Research Chemical
RESEARCH CHEMICALS are chemical substances used by scientists for medical and scientific research purposes . One characteristic of a research chemical is that it is for laboratory research use only; a research chemical is not intended for human or veterinary use. This distinction is required on the labels of research chemicals, and is what exempts them from regulation under parts 100-740 in Title 21 of the Code of Federal Regulations ( 21CFR ). CONTENTS* 1 Background * 1.1 Pharmacological research chemicals * 1.2 Agricultural research chemicals * 2 See also * 3 References BACKGROUNDPHARMACOLOGICAL RESEARCH CHEMICALS See also: Prohibition of drugs Research
Research
chemicals are fundamental in the development of novel pharmacotherapies
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List Of German Drug Laws
In Germany, several laws govern drugs (both recreational and pharmaceutical). * Betäubungsmittelgesetz (BtMG), regulates narcotics and contains explicit lists of those covered: Anlage I (authorized scientific use only), Anlage II (authorized trade only, not prescriptible) and Anlage III (special prescription form required). The lists contain some exceptions for lower doses. Betäubungsmittel-Verschreibungsverordnung (BtMVV), regulates the prescription of Anlage III narcotics on the special prescription form * Arzneimittelgesetz (AMG), covers prescription drugs , pharmacy-only and general sales list drugs. * Verordnung über die Verschreibungspflicht von Arzneimitteln, also known as Arzneimittelverschreibungsverordnung (AMVV), executive order that explicitly lists prescription drugs
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Food And Drug Board Of Authority
The FOOD AND DRUG BOARD OF AUTHORITY (Burmese : အစားအသောက်နှင့် ဆေးဝါးကွပ်ကဲရေး ဦးစီးဌာန; abbreviated FDBA) is Burma's national regulatory agency, responsible for regulation of therapeutic goods , including the manufacture, import, export, storage, distribution and sale of food and drugs, in the interests of public safety. The agency was established under the 1992 National Drug Law. According to the 1992 law, the membership is led by the Minister of Health and Deputy Minister of Health, who act as Chairman and Vice-Chairman respectively. FDBA is the highest authority of food and drug regulations. SEE ALSO * Ministry of Health (Burma) * Food and Drug Administration (Burma) REFERENCES * ^ A B "The National Drug Law" (PDF). The State Law and Order Restoration Council. 30 October 1992. Retrieved 6 July 2015. * ^ Holloway, Kathleen A (30 December 2011)
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