The European Medicines Agency (EMA) in February 2017 launched a public consultation on the proposed revision to its policy on access to documents. The new version extends the scope of the EMA’s existing policy and includes new access rules for corporate documents held by the EMA, and new access rules for documents related to medicines for human and veterinary use held by the EMA.
In a world first, the EMA in October 2016 made some clinical study reports (CSRs) broadly accessible. Other regulators, including the FDA, still do not disclose CSRs.
According to an article by Univadis:
“Since then, [the EMA] has released more than 2 million pages of regulatory documents that previously would have been considered confidential. Earlier this month, the EMA, for the first time, released clinical data supporting an application that was subsequently withdrawn.”
An in-depth analysis of the EMA’s policy regarding CSRs can be found in this blog by the AllTrials campaign.
The deadline for comments on the proposed EMA policy revisions is 18 May 2017.