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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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.
Global Medtech Guidance Tracker: March 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-four documents have been posted on the tracker since its last update.