It’s Started: EMA Proactively Publishes Clinical Data On New Drugs
The European Medicines Agency has delivered on its promise to grant public access to clinical reports that form the basis of its recommendations to the European Commission on whether or not a medicine should be authorized for use in the EU.
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EMA To Focus On Filings For Novel Drugs Under Restart Of Trial Transparency Policy
The European Medicines Agency is working on restarting its landmark policy on publishing clinical trial data, with the first phase expected to start this year.
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.
Canada Launches Portal To Proactively Disclose Clinical Data On Approved Devices, Drugs
Following in the footsteps of the European Medicines Agency, Canada has launched a publicly-accessible portal to proactively disclose clinical trial information on approved medical devices and drugs that was hitherto considered confidential.