Tag Archives: EMA

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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European Regulator’s Last Ditch Attempt at Transparency

By Peter O’ Donnell. The European Medicines Agency is determined to minimize opposition to its next moves on releasing clinical trial data. It announced last week yet another consultation on its plans to publish the results of trials — a policy it initially aimed at introducing from the beginning of this year. The latest twist […]
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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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Adaptive Licensing: The Start of a Slow Revolution in Europe

By Peter O’ Donnell. So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation. Is this the beginning of the end of binary decision-making on the merits of a new medicine? Has a half-century of the “yes/no” authorization process peaked, to be replaced […]
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Europe Approves First Medicine for Castleman's Disease

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Sylvant (siltuximab) for adult patients with multicentric Castleman’s disease.
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