Tag Archives: EU

EMA to Review Safety of Ibuprofen Medicines

The European Medicine Agency’s Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines.
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EU Steps Up Manufacturing Inspection Efforts

One of EMA’s key objectives this year is improvements in dealing with the “causes and impact of shortages of human medicines caused by GMP non-compliance and quality defects”. The European Directorate for the Quality of Medicines & Healthcare, which is responsible for the European Pharmacopoeia but also runs its own inspection operations, has been tightening […]
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European Pharma Must Get Its Data in Order

New data maintenance guidelines have sparked a flurry of activity in Europe. Organizations are still grappling with electronic submissions, and the need to update data is intensifying the pressure. But there is an upside, says Miranda Pothiawala. Earlier this year formal guidelines on how to maintain and update data submitted to the extended EudraVigilance Medicinal […]
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Six Steps to Better Cancer Care in Europe

A  report published yesterday provides recommendations for combating the “significant inequalities” affecting access to quality cancer care in Europe.
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"Work to Be Done" on EU Clinical Trials Regulation, Says Industry

The European Parliament yesterday voted towards the adoption of the new Clinical Trials Regulation, which removes the legal framework for pharma to not publish its data by stating that information from  trial study reports should not be considered commercially confidential.
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