Regulation of therapeutic goods

Regulation of Therapeutic Goods

The Regulation of Therapeutic Goods refers to the process by which government agencies oversee the development, testing, manufacturing, and distribution of therapeutic goods such as medicines, medical devices, and biological products.

Pronunciation

• Regulation: /ˌrɛɡjʊˈleɪʃən/
• Therapeutic: /ˌθɛrəˈpjuːtɪk/
• Goods: /ɡʊdz/

Etymology

The term "Regulation of Therapeutic Goods" is derived from the combination of three words. "Regulation" comes from the Latin regulare, meaning "to control". "Therapeutic" is derived from the Greek therapeutikos, meaning "serving to heal". "Goods" is a term of Old English origin, meaning "property or possessions".

Related Terms

• Pharmacovigilance
• Clinical Trials
• Good Manufacturing Practice
• Quality Assurance
• Risk Management

Overview

The regulation of therapeutic goods is crucial to ensure the safety, efficacy, and quality of these products. This process involves a series of steps, including preclinical testing, clinical trials, post-market surveillance, and pharmacovigilance.

Regulatory authorities such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and the Therapeutic Goods Administration (TGA) in Australia are responsible for the regulation of therapeutic goods in their respective regions.

See Also

• Drug Development
• Medical Device Regulation
• Biologics Regulation

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