World Pharma News - Strengthening pharmacovigilance to reduce adverse effects of medicines

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Strengthening pharmacovigilance to reduce adverse effects of medicines

Posted by worldpharmanews 461 days ago (http://www.worldpharmanews.com)
Category: Research & Development | Tags: pharmacovigilance ec

Medicinal products contribute considerably to the health of EU citizens. They can, however, also have adverse effects. It is estimated that 5% of all hospital admissions are due to an adverse drug reaction (ADR), and that ADR is the fifth most common cause of hospital death. In light of experience and following an assessment made of the EU pharmacovigilance system (supervision and monitoring of ADR) made by the Commission it has become clear that new measures are necessary to improve how the EU rules operate on the pharmacovigilance of medicinal products. Today's proposals seek to change the existing EU legislation on pharmacovigilance (provisions in Regulation (EC) No 726/2004 and Directive 2001/83/EC). They aim at strengthening and rationalizing the EU pharmacovigilance system, with the overall objectives of better protecting public health, ensuring proper functioning of the internal market and simplifying the current procedures.
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