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07-SEPTEMBER-2008 03:17:44 - 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. 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 1 Australia 2 Brazil 3 China 4 Europe 4.1 European Union 4.1.1 United Kingdom 4.2 Norway 4.3 Iceland 4.4 Switzerland 5 India 6 United States 7 See also 8 References 9 External links Australia Therapeutic goods in Australia are regulated by the Therapeutic Goods Administration TGA.1 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. 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 See also Illicit drug use in Australia 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.2 China The regulation of drugs in China is governed by the State Food and Drug Administration. Europe European Union See EudraLex, European Medicines Agency, and Directive 65/65/EEC1. 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 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. Norway Medicines in Norway are divided into five groups: Class A - Narcotics like morphine and methylphenidate require a special prescription form. Class B - Restricted substances which easily lead to addiction like co-codamol and diazepam 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 Iceland Medicines in Iceland are regulated by the Icelandic Medicines Control Agency 1. Switzerland Medicines in Switzerland are regulated by SwissMedic.3 The country is not part of the European Union, and is regarded by many as one of the easiest places to conduct clinical trials on new drug compounds. India Medicines in India are regulated by The Drugs Controller General of India DCGI.4 United States U.S. drug regulation Prescription drugs Over-the-counter drugs Law Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption Government agencies United States Department of Health and Human Services Food and Drug Administration Drug Enforcement Administration National Institutes of Health Center for Drug Evaluation and Research Process Drug development New drug application Investigational new drug Clinical trial Phase I, II, III, IV Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval International coordination International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs Non-governmental organizations Institute of Medicine Research on Adverse Drug events And Reports This box: view talk Therapeutic goods in the United States are regulated by the Food and Drug Administration FDA, which makes some drugs available over the counter at retail outlets and others by prescription only. The possession of some substances is prohibited by scheduling under the Controlled Substances Act, under the joint jurisdiction of the FDA and the United States Department of Justice. See also International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre WHO Council for International Organizations of Medical Sciences CIOMS, WHO Drug Efficacy Study Implementation DESI Validation drug manufacture Over-the-counter drug Prescription drug Counterfeit drug World Health Organization References ^ TGA - Therapeutic Goods Administration ^ Anvisa - The History Of Health Surveillance In Brazil ^ Swissmedic ^ CDSCOCentral Drugs Standard Control Organisation External links Food and Drug Administration US Central Drug standard Control OrganisationIndia Presentation on Drug License Audit Process in India v d e Drug control laws Americas Brazil · Canada · United States Eurasia European Union · India · Netherlands · Norway · Switzerland · United Kingdom Oceania Australia Retrieved from http://en..org/wiki/Regulation_of_therapeutic_goods Categories: Pharmaceuticals policy | Pharmacy Views Article Discussion this page History Personal tools Log in / create account Navigation Main page Contents Featured content Current events Random article Search Go Search Interaction Community portal Recent changes Contact Donate to Help Toolbox What links here Related changes Upload file Special pages Printable version Permanent link Cite this page Languages Deutsch Suomi Français Türkçe This page was last modified on 25 June 2008, at 02:23
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