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Pharmaceuticals / Postmarket Safety

EMA’s PRAC Revises Methods for Measuring Pharmacovigilance Impacts

Dec. 6, 2017

The European Medicines Agency’s pharmacovigilance committee revised its methods for measuring the health outcomes of its major regulatory interventions, aiming to improve industry safety monitoring practices and find out which activities have been the most successful.

The Pharmacovigilance Risk Assessment Committee also launched two safety reviews — of Gedeon Richter’s Esmya (ulipristal) in the treatment of benign uterine fibroids, and of Bayer’s prostate cancer radiopharmaceutical Xofigo (radium-223 dichloride).

In addition, the PRAC confirmed its September recommendation that extended-release paracetamol pain relievers be removed from the market.

The revisions to the January 2016 strategy combine patient and professional knowledge of risks, changes in behavior and use and changes in morbidity and mortality. It is focused on the effectiveness of risk minimization, pharmacovigilance processes, stakeholder engagement and analytical methods.

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