Transcription of DEVELOPMENT SAFETY UPDATE REPORT - ICH
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DEVELOPMENT SAFETY UPDATE REPORT - ICH
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL. REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE. ICH HARMONISED TRIPARTITE GUIDELINE. DEVELOPMENT SAFETY UPDATE REPORT . E2F. Current Step 4 version dated 17 August 2010. 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 USA. E2F. Document History Code History Date E2F Approval by the Steering Committee under Step 2 5 June and release for public consultation. 2008. Current Step 4 version E2F Approval by the Steering Committee under Step 4 17 August and recommendation for adoption to the three 2010. ICH regulatory bodies. DEVELOPMENT SAFETY UPDATE REPORT .
The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development (including
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