BLG 699 Chapter Notes - Chapter 3: B-Cell Chronic Lymphocytic Leukemia, Title 21 Of The Code Of Federal Regulations, Sofosbuvir
26 Sep 2016
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There are legislations that require drugs to be: developed, tested, trialed, and manufactured in accordance to guidelines so that they are safe and patients" well-being is protected. Drugs are tested on animals by following: glp (good lab practices) Drugs are tested on humans by following: gcp (good clinical practices) Drugs are manufactures by following: gmp (good manufacturing practices) Canada health products and food branch (hpfb) of health canada. Japan ministry of health and labor welfare (mohlw) with pharmaceutical agencies and medical device agencies (pmda) as regulatory review. Opportunity markets (om) or merging markets: asia, latin america, central and eastern europe, middle east, and africa have independent nras. It"s role is to ensure that drugs are developed, manufactured, and marketed in accordance with regulatory requirements so that they"re safe and effective. The fda has four centers and a regulatory office. Ind is sent to fda to start clinical trials.
