Regulatory Agency Transparency for Drugs and Biologics: A Comparative Survey of the US Food and Drug Administration, the European Medicines Agency, and Health Canada

摘要

This survey paper compares practices of the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada (HC) across key information and data disclosure requirements as well as practices across processes for obtaining marketing approval for drug products. As this survey illustrates, FDA, EMA, and HC share many procedural commonalities, but also differ in significant respects. That said, each regulatory agency has described its commitment to regulatory transparency in a similar way, focusing on benefits to public health, research and development, and patients. Further analysis can determine the pros and cons of specific enhancements in transparency, including whether greater transparency results in regulatory efficiencies.