alexa Recent Developments in EU and US Pharmacovigilance Legislation

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Recent Developments in EU and US Pharmacovigilance Legislation

According to the European Commission’s data, a) 5% of all hospital admissions are due to ADR; b) 5% of all hospital patients experience an ADR; c) on average, ADRs cause at least 1.91 extra days of hospitalization; d) ADRs are the 5th most common cause of hospital death. Also in the United States, ADRs contribute to more than 100.000 deaths annually and are among the top 10 leading causes of death. This situation makes clear the importance of pharmacovigilance, as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or other drug related problems”.

Citation: Montanari-Vergallo G (2013) Recent Developments in EU and US Pharmacovigilance Legislation. J Pharmacovigilance 1:e105.

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