Ectd backbone
Found 5 free book(s)ICH M2 EWG
estri.ich.orgICH eCTD STF Specification V 2.6.1 3-June-2008 The eCTD Backbone Files Specification for Study Tagging Files Revision History Date Version Summary of Changes
ICH M2 EWG - International Council for Harmonisation of ...
estri.ich.orgICH eCTD Specification V 3.2.2 16-July-2008 Page 1 ICH eCTD Specification Introduction The ICH M4 Expert Working Group (EWG) has defined the Common Technical Document (CTD).
Version 1.4.1 November 2011 - Europa
esubmission.ema.europa.euIn line with the general principles of the ICH eCTD Specification, it is intended that XML will eventually become the sole submission format for administrative forms and product information
EU Module 1 eCTD Specification - Europa
esubmission.ema.europa.eu3 types, clarifications how to use new submission types and submission unit types. 2.4.1 29.09.2015 K. Menges Reconciliation of comments from public consultation.
Provisional Translation (as of July 2015)
www.pmda.go.jpProvisional Translation (as of July 2015) * * This English version of the Japanese Notification is provided for reference purposes only. In the event of