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Encyclopedia > 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. For other uses, see State (disambiguation). ...


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.

Contents

Australia

Therapeutic goods in Australia are regulated by the Therapeutic Goods Administration (TGA). The availability of drugs and poisons is regulated by scheduling under individual state legislation, but is generally under the guidance of the national Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia. ... The Standard for the Uniform Scheduling of Drugs and Poisons, abbreviated SUSDP, is a document used in the regulation of drugs and poisons in Australia. ...


Under the SUSDP, medicinal agents generally belong to one of five categories:

  • Unscheduled/exempt
  • Schedule 2 (S2) - Pharmacy Medicines
  • Schedule 3 (S3) - Pharmacist Only Medicines
  • Schedule 4 (S4) - Prescription Only Medicines
  • Schedule 8 (S8) - Controlled Drugs

Brazil

Therapeutic goods in Brazil are regulated by the Brazilian Health Ministry, Through its Sanitary Surveillance Agency (equivalent to USA's FDA). There are 5 main categories:

  • Normal Medicines - Cough, cold and fever medicines, antiseptics, vitamins and others. Sold freely in pharmacies and some large supermarkets.
  • Red Stripe Medicines - These medicines are sold only with medical prescription. Antibiotics, Anti allergenics, Anti inflamatories, and other medicines. In Brazil, governmental control is loose on this type; it is not uncommon to buy this type of prescription medicine over the counter without a prescription.
  • Red Stripe Psychoactive Medicines - These medicines are sold only with a "Special Control" white medical prescription with carbon copy, which is valid for 30 days. The original must be retained by the pharmacist after the sale and the patient keeps the carbon copy. Drugs include anti-depressants, anti-convulsants, some sleep aids, anti-psychotics and other non-habit-inducing controlled medicines. Though some consider them habit inducing, anabolic steroids are also regulated under this category.
  • Black Stripe Medicines - These medicines are sold only with the "Blue B Form" medical prescription, which is valid for 30 days and must be retained by the pharmacist after the sale. Includes sedatives (benzodiazepines), some anorexic inducers and other habit-inducing controlled medicines.
  • "Yellow A Form" prescription medicines - These medicines are sold only with the "Yellow A Form" medical prescription - the most tightly controlled, which is valid for 30 days and must be retained by the pharmacist after the sale. Includes amphetamines and other stimulants (such as methylphenidate), opioids (such as morphine and oxycodone) and other strong habit-forming controlled medicines. ([1])

An antiseptic solution of Povidone-iodine applied to an abrasion Antiseptics (Greek αντί, against, and σηπτικός, putrefactive) are antimicrobial substances that are applied to living tissue/skin to reduce the possibility of infection, sepsis, or putrefaction. ... Retinol (Vitamin A) For the record label, see Vitamin Records A vitamin is an organic compound required in tiny amounts for essential metabolic reactions in a living organism. ... An antibiotic is a drug that kills or slows the growth of bacteria. ... Anti-inflammatory refers to the property of a substance or treatment that reduces inflammation. ... ... The anticonvulsants, sometimes also called antiepileptics, belong to a diverse group of pharmaceuticals used in prevention of the occurrence of epileptic seizures. ... A sedative is a drug that depresses the central nervous system (CNS), which causes calmness, relaxation, reduction of anxiety, sleepiness, slowed breathing, slurred speech, staggering gait, poor judgment, and slow, uncertain reflexes. ... Benzodiazepine tablets The benzodiazepines are a class of drugs with hypnotic, anxiolytic, anticonvulsant, amnestic and muscle relaxant properties. ... Vitamin R redirects here. ... An opioid is any agent that binds to opioid receptors found principally in the central nervous system and gastrointestinal tract. ... This article is about the drug. ...

European Union

See EudraLex, European Medicines Agency, and Directive 65/65/EEC1. EudraLex is the collection of rules and regulations governing medicinal products in the European Union. ... The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. ... Directive 65/65/EEC1 was the first European pharmaceutical directive. ...


India

Medicines in India are regulated by The Drugs Controller General of India (DCGI). http://www.cdsco.nic.in/


Norway

Medicines in Norway are divided into five groups:

  • Class A - Narcotics like Morphine and Ritalin require a special prescription form.
  • Class B - Restricted substances which easily lead to addiction like Paralgin Forte and Valium
  • Class C - All prescription-only substances
  • Class F - Substances and package-sizes not requiring a prescription
  • Unclassifieds - Brands and packages not actively marketed in Norway

This article is about the drug. ... Methylphenidate (C14H19NO2), or MPH, is an amphetamine-like prescription stimulant commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adults. ... Diazepam, brand names: Valium, Seduxen, in Europe Apozepam, is a 1,4-benzodiazepine derivative, which possesses anxiolytic, anticonvulsant, sedative and skeletal muscle relaxant properties. ...

Switzerland

Medicines in Switzerland are regulated by SwissMedic (http://www.swissmedic.ch/?lang=2&lang_old=2). The country is NOT part of the EU (as of 2007), and thus is regarded as many as one of the easiest places to conduct clinical trials on new drug compounds.


United Kingdom

Medicines in the United Kingdom are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The availability of drugs is regulated by classification by the MHRA as part of marketing authorisation of a product. The logo of the MHRA. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. ...


The United Kingdom has a three-tiered classification system:

  • General Sale List (GSL)
  • Pharmacy medicines (P)
  • Prescription Only Medicines (POM)

Within POM, certain agents with a high abuse/addiction liability are separately scheduled under the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001; and are commonly known as Controlled Drugs (CD). The Misuse of Drugs Act 1971 is an Act of Parliament, by which the United Kingdom aims to control the possession and supply of numerous drugs and drug-like substances, as listed under the Act, and to enable international co-operation against illegal drug trafficking. ... The United Kingdom Misuse of Drugs Act 1971 aimed to control the possession and supply of numerous listed drugs and drug-like substances. ...


United States

Therapeutic goods in the United States are regulated by the Food and Drug Administration (FDA). The availability of controlled drugs is regulated by scheduling under the Controlled Substances Act. “FDA” redirects here. ... The Controlled Substances Act (CSA) was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. ...


The United States has a two-tiered system:

  • Overcounter (OTC)
  • Prescription only (Rx-only)

See also

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical... The Uppsala Monitoring Centre (the UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. ... The Council for International Organizations of Medical Sciences (CIOMS) is an international, nongovernmental, not-for-profit organization established jointly by WHO and UNESCO in 1949. ... This was a program begun by the FDA in the 1960s after the requirement that all drugs be efficacious as well as safe. ... The tone or style of this article or section may not be appropriate for Wikipedia. ... Over-the-counter substances, also abbreviated OTC, are drugs and other medical remedies that may be sold without a prescription and without a visit to a medical professional, in contrast to prescription only medicines (POM). ... A prescription drug is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. ... A counterfeit drug or a counterfeit medicine is a medication which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. ...

External links

  • Food and Drug Administration (US)(F.D.A)Italic text

  Results from FactBites:
 
Regulation of therapeutic goods - Wikipedia, the free encyclopedia (698 words)
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).
Medical Devices (3990 words)
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.
  More results at FactBites »

 
 

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