 The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially.Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the authoring of the IB in the European Union (EU), Japan, and the United States (US).As part of its guidance on good clinical practice (GCP), the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the contents of the IB in the European Union (EU), Japan, and the United States (US).