Ectd Backbone Files Specification
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The eCTD BACKBONE FILES SPECIFICATION FOR MODULE 1
www.fdanews.comThe eCTD Backbone Files Specification f or Module 1 Version 2.3 4 3. Submission-description Element The submission-description element is an optional field that allows up to 128 characters. Only the first 128 characters of the submission description element will be displayed.
EU Module 1 eCTD Specification - Europa
esubmission.ema.europa.euformat PDF, as defined by the ICH eCTD Specification Document, XML and image formats are also accepted on an ad hoc basis. Note that all PDF files included in an eCTD (irrespective of the module) should be v1.4, v1.5, v1.6 or v1.7 (see ICH Q&A for further detail re …
EU Module 1 eCTD Specification - Europa
esubmission.ema.europa.euAppendix 2 of the ICH eCTD specification. Where a section is not applicable, this section need not be included in the XML, nor should a directory be created in the directory structure. 1 This is any number, used by an agency or the applicant to track the submission, in any procedure, in relation to a particular product.