The European Medicines Agency ("EMA") has published a video and presentations from its June 24, 2015, webinar, which provide an update on the implementation of its Transparency Policy. The policy came into force on January 1, 2015, and applies to clinical reports contained in all marketing-authorization applications submitted on or after this date. The webinar provides 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 anonymization of clinical reports for purposes of publication.
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