Public consultation on the publication and access to clinical-trial data now closed

News 01/10/2013

The European Medicines Agency's (EMA's) three-month public consultation on its PDF icon draft policy on publication and access to clinical-trial data ended yesterday, 30 September 2013.

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, 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.

The Agency would like to thank all contributors for their comments, which were both constructive and helpful in clarifying some of the issues at stake. All comments submitted will now be considered by the Agency as it finalises the policy, before the end of the year. Pending 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 the comments received.

The Agency expects the policy to come into force on 1 January 2014. An implementation plan is under preparation.

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