-
E3 Clinical Study Reports
Code Document Title Previously coded -
Finalised Guideline:
November 1995Description :The tripartite harmonised ICH Guideline was finalised under Step 4 in November 1995. This document describes the format and content of a study report that will be acceptable in all three ICH regions. It consists of a core report suitable for all submissions and appendices that need to be available but will not be submitted in all cases.
Implementation ::Step 5
:EC, Europe - Adopted by CPMP, December 1995, issued as CPMP/ICH/137/95
:MHLW/PMDA, Japan - Adopted May 1996, PAB/PCD Notification No. 335
:FDA, US - Published in the Federal Register, 17 July 1996, Vol. 61, p. 37320
:Health Canada, Canada - Implemented 20 May 1997, Catalogue No. H42-2/67-10-1996E
Swissmedic, Switzerland - Refer to the press release on Swissmedic, Switzerland's website
-