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References

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Written by Alondra Sandoval

  1. “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

  2. “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

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

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

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

  6. “Guidance for Industry - Preparation of Drug Submissions in eCTD Format”, Health Canada, 2009/11/04

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

  8. “Swiss Module 1 Specification for eCTD”, Swissmedic, 1.0.1, 4 December 2009

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

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

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

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