The purpose of a pharmaceutical regulatory body is to govern and regulate the industry. As customers / users of medicinal products we need to be assured that:
• When it comes to manufacturing a medicinal product that patient safety and product quality will not be compromised by poor or bad manufacturing practices. In effect we need bodies that not only advise on but set guidelines and rules for Good Manufacturing Practices (GMP) in order that the risks associated with patient safety and product quality are mitigates as far as is reasonably possible.
• When medicinal products are approved and supplied, we need the relevant assurances of their quality safety and efficacy. In essence medicinal products must do what they are intended to do with the relevant therapeutic effect/s.
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The EMA advises on relevant guidelines and mandatory rules and regulations in order to have a license to produce distribute or sell approved medicinal products in its member states. In the USA the relevant regulatory authority body is the FDA (Food and Drug Administration). The FDA advises on guidelines and mandatory rules and regulations in order to have a license to produce distribute or sell approved medicinal products in the US market place.
The USA FDA is described as: “a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation 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 emitting devices (ERED), cosmetics, animal foods & feed[5] and veterinary products..”
So what does this mean for the pharmaceutical