The International Council for Harmonisation (ICH) is a global body that develops harmonized guidelines for pharmaceutical development and clinical research.
ICH guidelines, such as ICH E6 for Good Clinical Practice, shape how protocols are designed, monitored, documented, and reported across regions. Sponsors use ICH guidance to align trial conduct with regulator expectations in the U.S., EU, Japan, and other markets. Consistent use supports data acceptability across jurisdictions and reduces duplication in global development programs. ICH standards also strengthen participant protection by setting expectations for oversight, safety reporting, and quality management.