Regulation of therapeutic goods
From Wikipedia, the free encyclopedia
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.
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[edit] 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:
See also Illicit drug use in Australia
[edit] 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:
[edit] China
The regulation of drugs in China is governed by the State Food and Drug Administration.
[edit] Europe
[edit] European Union
See EudraLex, European Medicines Agency, and Directive 65/65/EEC1.
[edit] 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:
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).
[edit] Norway
Medicines in Norway are divided into five groups:
[edit] Iceland
Medicines in Iceland are regulated by the Icelandic Medicines Control Agency [1].
[edit] 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.
[edit] India
Medicines in India are regulated by The Drugs Controller General of India (DCGI).[4]
[edit] United States
Over-the-counter drugs
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.
