| Regulation Of Therapeutic Goods |
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| CATEGORIES ABOUT REGULATION OF THERAPEUTIC GOODS | |
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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. AUSTRALIA Therapeutic goods in (SUSDP). Under the SUSDP, medicinal agents generally belong to one of five categories:
BRAZIL Therapeutic goods in the Brazil are regulated by the Brazilian Health Ministry . There are 3 main categories:
EUROPEAN UNION See European Medicines Agency . 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 Medicines Control Agency 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 Drug s (CD). 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 . EXTERNAL LINKS |
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