22 September 2015 - The European Medicines Agency (EMA) has published today the presentations and summaries of the discussions held at two face-to-face meetings organised on 6 July and 7 September 2015 to provide stakeholders with an update on the implementation of its policy on publication of clinical data.

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 publication of the first reports is foreseen for mid-2016.

To help stakeholders understand the requirements and prepare for the publication of clinical reports, the Agency organised a series of further discussions and consultations to explain the work processes which are foreseen.

A webinar was first organised on 24 June to provide stakeholders with an overview of how the policy will concretely be implemented.

EMA then organised a face-to-face meeting on 6 July with patients' organisations, academia, representatives of national competent authorities and industry associations. This allowed more detailed discussions on two sets of guidance under development, on the identification and redaction of commercially confidential information in clinical reports submitted to the EMA for publication, and on the anonymisation of clinical reports, in the context of the policy.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/09/news_detail_002398.jsp&mid=WC0b01ac058004d5c1