The draft policy outlines rules for publication and access to clinical-trial data submitted to the EMA as part of a marketing-authorisation application, once the decision-making process has ended.
More than 150 individuals and organisations submitted over 1,000 comments during this consultation. Healthcare professionals, academics and the pharmaceutical industry responded in broadly similar numbers and together represented almost half of all contributors. There was also significant input from patient organisations, regulatory authorities and health-technology assessment bodies and payers. A large proportion of respondents were individual citizens expressing their support for the EMA’s initiative to increase clinical-trial data transparency.
Pending an endorsement by the EMA Management Board at its 12 December meeting, once the policy is finalised it will be published on the EMA website together with an overview of comments received. The Agency expects this policy to come into force on 1 January 2014. An implementation plan is under preparation.