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.
The European Medicines Agency is developing a strategy to ensure that women have sufficient information to make informed choices about taking medicines during pregnancy and breastfeeding.