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.
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Following a public consultation earlier this year, Health Canada has asked for expert advice on its plans to allow the release of clinical data that is currently considered confidential. It expects to publish draft regulations this autumn.
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.
Nearly all of the clinical trial data in new drug marketing applications that are submitted to the European Medicines Agency for evaluation after 1 January 2015 will be made available to the public following the drug's approval, the agency's eagerly-awaited final policy on proactive publication of trial data has revealed1-3.