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EMA & Health Canada Harmonize Anonymization Reporting For Clinical Trial Reports

 
• By Vibha Sharma

Companies submitting clinical data for publication under the European Medicines Agency's Clinical Data Publication policy and Health Canada's Public Release of Clinical Information initiative can now provide a single anonymization report to both regulators. This report would explain the steps taken by sponsors to ensure the anonymized data poses a low risk of re-identification.

3D rendering of the flags of Canada and European Union on grunge woven fabric texture. Canada-European Union Comprehensive Economic and Trade Agreement (CETA) concept.
EMA and Health Canada are seeking to align their clinical data transparency requirements • Source: Shutterstock

The European Medicines Agency and Health Canada have published a harmonized template that drug sponsors can use to explain what anonymization methodology they have applied to their clinical study reports (CSRs) submitted for disclosure under the clinical trial transparency policies in the two regions.

The anonymization report template will support the implementation of the EMA’s relaunched Clinical Data Publication (CDP) policy and Health Canada’s

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