Big Win For EMA On Transparency
Court Says Clinical Study Reports Are Not Presumptively Confidential
The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.
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Guido Rasi - The Face Of The EMA For A Decade
The head of the European Medicines Agency is nearing the end of his tenure. We consider Guido Rasi’s achievements over the past 10 years as well as the controversies that have arisen under his leadership – and report that sailing is likely to figure in his plans for life after the agency.
Patent Settlements May Break EU Law
Patent-litigation settlements reached almost 20 years ago in the UK over GSK’s Seroxat paroxetine antidepressant may contravene EU competition law, an advocate general has advised the CJEU.
Transparency Advocates Urge Upholding EMA’s Access To Documents Policy
A number of transparency supporters have issued an open letter ahead of an EU court judgment on the European Medicines Agency’s access to documents policy.