Transparency Advocates Urge Upholding EMA’s Access To Documents Policy
Voice Concern Over Impact Of Recent Opinions By EU Advocate General
Executive Summary
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.
You may also be interested in...
Big Win For EMA On Transparency
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.
EMA Loses Key Round In Court Battle For Flagship Transparency Policy
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.
Care Needed With Plain Language Summaries Of EU Study Results
The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.