Effective Pharmacovigilance Systems to Ensure Drug Safety

The U.S. FDA regulates food, drugs, cosmetics, medical devices, tobacco, and radiationemitting electronic products. FDA falls within the Department of Health and Human Services and headed b the !ommissioner of Food and Drugs, appointed b the "resident, and confirmed b the U.S. Senate. The #ffice of the !ommissioner oversees all the Agenc $s components and is responsible for the efficient and effective implementation of FDA$s mission.

FDA$s #ffice of the !ommissioner is divided into departments. The #ffice of %edical "roducts and Tobacco oversees the !enter for Drug &valuation and 'esearch which regulates drug products sold in the U.S. These include( Active Pharmaceutical Ingredients (API): An Active "harmaceutical )ngredient is an substance or mi*ture of substances intended to be used in the manufacture of a medicinal product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activit or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the bod . Drug Intermediates: These are materials produced during the steps in the s nthesis of an Active "harmaceutical )ngredient +A"), that must undergo further molecular change or processing before becoming an A"). Prescription Drugs: is a human drug that is not safe for use e*cept under the supervision of licensed medical practitioner. Over the Counter (O C) Drugs: is a human drug that is safe and effective for use without prescription b a licensed medical !riting services practitioner. "omeopathic Drugs: A homeopathic drug is an drug labeled as being homeopathic which is listed in the Homeopathic "harmacopeia of the United States +H"US,, an addendum to it, or its supplements. Animal Drugs: A new animal drug is defined, in part, as an drug intended for use in animals other than man, including an drug intended for use in animal feed but not including the animal feed, the composition of which is susar that the drug is not generall recogni-ed as safe and effective for the use under the conditions prescribed, recommended, or suggest in the labeling of the drug.

#edical $ases: %edical gases +e.g. o* gen, carbon dio*ide, helium, nitrogen, nitrous o*ide, medical air, and ./ combinations of these, are drugs within the meaning of section 012+g,+2, of the Federal Food, Drug, and !osmetic Act +Act, and, pursuant to section 314+b,+2,+A, of 32 the Act, are re5uired to be dispensed b prescription. The Drug &stablishment 'egistration with FDA must be submitted annuall . The Food and Drug Administration Safet and )nnovation Act +FDAS)A, re5uires drug companies to submit annual establishment registrations during the period from #ctober 2 to December 42 of each calendar ear. Firms must also list an drugs not previousl listed during this period. Following the incessant health troubles evo6ed b pharmaceutical drugs, a ma7or emphasis has been placed on ensuring drug safet . "harmacovigilance has a ma7or role to pla in doing so. )t helps in detection, assessment, research and prevention of adverse side effects b drugs. Since it has such an important function in ensuring drug safety services, an effective methodolog that optimall recogni-es the damage causing factor in a particular drug and helps eliminate that factor should be designed. Different pharmaceutical firms use different Pharmacovigilance methods. The comprehensiveness of the s stem is ver important in detecting the problem causing element in the drug 5uic6l and most precisel . #ver the past decade there has been a shift in the drug safet standards, driven b the regulator authorities. The policies on ris6 management and the standards of pre mar6eting and post mar6eting techni5ues have been made stringent. This has created a need to constantl document ever detail of manufacture, pre mar6eting and post mar6eting aspects of each drug. )t has become important for drug manufacturers to increase the transparenc of their activities and maintain intra industr , inter industr and consumer communication about various aspects about the drug.