EMA REFORMS EUDRAVIGILANCE DATABASE ACCESS
September 1st, 2014
THE EUROPEAN Medicines Agency (EMA) is consulting on proposed changes to rules governing access to its EudraVigilance database of suspected reported adverse reactions to authorised medicines. It receives more than one million adverse drug reaction (ADR) reports annually.EMA wants to boost access to take account of recent European Union (EU) pharmacovigilance reforms that increase transparency, the introduction of direct patient reporting, and the pharmaceutical industry's revised responsibility for monitoring EudraVigilance data for new safety issues, following a ...
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