Healthcare Regulation Of The Pharmaceutical Industry

998 WordsAug 3, 20154 Pages
Healthcare Regulation The pharmaceutical industry is one of the most heavily regulated of all industries and Pfizer is a global US based pharmaceutical company and in the pharmaceutical industry companies are regulated by the Food and Drug Administration (FDA), World Health Organization (WHO), and Medicines and Healthcare Products Regulatory Agency (MHRA). Each of these regulatory bodies focus on the manufacturer, drug sellers, and prescribing to physicians process. (World Health Organization). In accordance to the Internal Revenue Service, the US firms must meet government regulatory requirements. The drug company must get market approval and show it safe for human consumption through animal and human testing and prove it is effective for the illness and its intentions to alleviate. The scientific community established a four-phase method to establish effectiveness. First phase is animal and toxicity studies, second phase is the investigational new drug application filed to test small numbers of human and allow transportation of unapproved drugs. Thirdly, a large scale trials conducted with thousands of patients proves the product is effective against a specific disease. Human trial subjects must provide consent for the experimental group. Lastly, a post approval marketing testing which are conducted to generate marketing data for the competitive market (involves competitor products) (Internal Revenue Service, 2015) These measures must be in compliance with the FDA in
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