Transcription of The eCTD BACKBONE FILES SPECIFICATION FOR MODULE 1
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The eCTD BACKBONE FILES SPECIFICATION FOR MODULE 1
The eCTD BACKBONE FILES SPECIFICATION for MODULE 1 Version The eCTD BACKBONE FILES SPECIFICATION FOR MODULE 1 Revision History Date Version Summary of Changes 2003-08-13 Original version 2004-03-01 Clarifications to the original version 2006-04-13 Change to Related Sequence Example 2006-12-13 Change to XML coding for a supplement to an original application related sequence example 2012-06-01 Change to reflect major modifications to MODULE 1 (admin) and the use of attributes (Summary of Changes in Appendix 2) 2012-11-01 Changes include updating the DTD version references and includes a copy of the updated DTD version in Appendix I (Summary of Changes in Appendix 2) 2013-08-23 Changes include two additional attributes for , updating the DTD version r
Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. For example, the path for the us-regional.xml file for sequence number 0006 is 0006/m1/us/us-regional.xml. Include a reference to a leaf element in the Module 2 to 5 eCTD Backbone File (index.xml) for the us-regional.xml file. In the corresponding ...
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