Update on publication of clinical data

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22/09/2015

Update on publication of clinical data

EMA publishes summaries and presentations from stakeholder consultations on the implementation of its policy on publication of clinical data

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.

EMA updated its draft guidance documents to reflect comments from stakeholders, and has further consulted on these with stakeholders at a follow up face-to-face meeting on 7 September. The Agency also presented new technical guidance on the procedural aspects related to the submission of clinical reports, i.e. practical matters of how material should be sent to EMA, as well as the workflow of the redaction consultation process and the overall process leading to publication. The technical guidance on how data should be sent to EMA will now be sent to industry associations for consultation.

As for the next steps in the implementation of the policy, EMA will meet in October with both the European Ombudsman and the European Data Protection Supervisor in order to consult with these institutions. 

Following these meetings, the two guidance documents on the identification and redaction of commercially confidential information in clinical reports for publication, and on the anonymisation of clinical reports in the context of the policy will be finalised for publication.

These documents will be updated in light of the experience gained during the implementation of the policy.

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