ICH HARMONISED TRIPARTITE GUIDELINE
– DEVELOPMENT SAFETY UPDATE REPORT
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USAGDE Error: Error retrieving file - if necessary turn off error checking (404:Not Found)