References

“Electronic Common Technical Document Specification”, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH M2 EWG, Version 3.2.2, 16-July-2008

“The eCTD Backbone File Specification for Study Tagging Files”, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH M2 EWG, Version 2.6.1, 3-June-2008

“The eCTD Backbone Files Specification for Module 1”, FDA, Version 1.3, 2006-12-13

“EU Module 1 Specification”, EMEA, Version 1.4, August 2009

“Guidance for Industry - Creation of the Canadian Module 1 eCTD Backbone File”, Health Canada, 2004/06/15

“GUIDANCE FOR INDUSTRY - Preparation of Drug Submissions in eCTD Format”, Health Canada, 2009/11/04

“Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD electronic Submissions”, Draft Version 1.0, May 2009

“Swiss Module 1 Specification for eCTD”, SwissMedic, 1.0.1, 4 December 2009

“Guidance for Industry on Providing Regulatory Information in eCTD Format”, SwissMedic, 1.0, 30 October 2009

“AU Module 1 Specification”, Version 2.1, November 2008

“Structure and Content of Clinical Study Reports: E3”, ICH, 30 November 1995