Transparency Advocates Urge Upholding EMA’s Access To Documents Policy
Voice Concern Over Impact Of Recent Opinions By EU Advocate General
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.
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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.
The European Medicines Agency may be forced to re-examine whether clinical trial data should be regarded as presumptively confidential under its access to documents policy.
While the Dutch government negotiates an acceptable price for Leadiant Biosciences’ orphan drug CDCA, a university hospital has resumed supplying pharmacy compounded versions of the drug after addressing initial problems with the sourcing of raw materials.