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Pharmaceutical company should submit all the relevant data on the safety and efficacy of the potential new drug including preclinical experimental data and clinical trial data to the regulatory agency for getting a marketing approval. The information on the safety of a new drug could not be collected comprehensively through premarketing clinical trials. Therefore, it is necessary to collect more information on the safety of newly marketed drug through effective monitoring system. There exists various source of safety information, such as spontaneous reporting system, re-examination system, active surveillance system, foreign data, academic paper and procedures of scientific meetings. Once a hypothesis on the association between adverse drug reactions and a specific drug has been provoked, pharmacoepidemiologic study should be conducted, and expeirmental study such as clinical trial can be used as a scientific study design. The purpose of this paper is mainly for explaining the concept and methods for effective monitoring of the adverse drug reactions.
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