Update on publication of clinical data

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29/06/2015

Update on publication of clinical data

EMA publishes video and presentations from the 24 June webinar on the implementation of its transparency policy

The European Medicines Agency (EMA) has published today the video recording of its webinar held on 24 June to provide an update on the implementation of its policy on the publication of clinical data, as well as the slides of all the presentations given.

The video and presentations are available on the EMA website.

EMA's policy on publication of clinical data entered into force on 1 January 2015 and applies to clinical reports contained in all marketing-authorisation applications submitted on or after this date. The first reports will be published as soon as a decision on the application has been taken, currently foreseen for mid-2016.

To help stakeholders anticipate the requirements and prepare for the publication of clinical reports, the Agency explained the work processes which are foreseen. The topics covered by the webinar included an explanation of the principles for the submission of redacted clinical reports, the redaction consultation process, as well as guidance on redacting commercially confidential information in clinical reports and on the anonymisation of clinical reports for the purpose of publication.

During the webinar, participants had the opportunity to comment interactively on these topics and share their views.

A face-to-face meeting will be organised on 6 July 2015 at the EMA to allow more detailed discussions on the draft guidance on anonymisation of clinical reports for publication and on redacting commercially confidential information in clinical reports. Stakeholder organisations have been contacted to nominate experts as participants in this meeting. The guidance is expected to be finalised and published after the summer.

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