Asked by: Kane Acuñas
asked in category: General Last Updated: 24th February, 2020

What is pharmaceutical regulation?

Pharmaceutical regulations, or medicines regulations, have been defined as the combination of legal, administrative, and technical measures that governments take to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information [12,13][12][13].

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Consequently, what is drug regulation?

Drug regulation is the control of drug use by international agreement and/or by regulatory authorities such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceutical and Medical Devices Agency (PMDA).

Additionally, does the FDA regulate pharmaceuticals? The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation

Keeping this in consideration, how is the pharmaceutical industry regulated?

Nearly all governments have some type of pharmaceutical regulatory body aimed at protecting citizens from the deleterious effects of harmful drugs. In the United States, the Food and Drug Administration (FDA) is responsible for ensuring pharmaceutical companies thoroughly test new products for efficacy and safety.

Why is drug regulation important?

The regulation of drugs and medicine is crucial to the health and safety of the public. Ensuring that a medicine is high quality is achieved by checking the efficacy, quality and safety of the drug. Regulation is important and followed continuously in every step and process that the drug material passes through.

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