Last month, EMA published summaries and presentations of the discussions held at two recent meetings on the implementation of its policy on clinical data publication. EMA's policy on clinical data publication went into effect on January 1, 2015 and applies to clinical reports contained in all marketing-authorization applications submitted on or after this date. The first reports are expected in mid-2016. EMA's next steps in implementing this policy are to consult with both the European Ombudsman and the European Data Protection Supervisor this month. Industry expects EMA to publish two guidance documents regarding the identification and redaction of commercially confidential information in clinical reports for publication, and the anonymization of clinical reports.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
