EMA Revises Guidance on Clinical Data Publication Policy

The European Medicines Agency has expanded the types of documents it will publish alongside clinical study reports from sponsors’ drug product applications.

The EMA clarified that all submitted clinical study reports referred to in applications that seek to modify product indications, as well as pediatric study extensions, will be subject to publication.

The agency added checklists for the validation stage and for redaction proposal documents, as well as a template for anonymization reports for applications that do not require patient identifiers.

Under the policy that went into effect last year, the agency began publishing clinical study data for any applications submitted after Jan. 1, 2015, including clinical overviews and data summaries, as well as in-depth study reports on trial methodology and results.