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FDAnews Drug Daily Bulletin
July 12, 2012 | Vol. 9 No. 136
Drugmakers Brace for IT Changes, Costs Related to EU Pharmacovigilance Regs
Beginning this month, drugmakers and competent authorities must report all adverse drug reactions — not just serious ones — to the EU’s centralized EudraVigilance database. The adverse event reporting requirements are one of a number of changes being implemented under new pharmacovigilance legislation that took effect July 2. The overhaul, which entails some major adjustments in companies’ IT and reporting systems, could be costly for manufacturers, industry said.
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