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GUIDANCE DOCUMENT

M8 Electronic Common Technical Document (eCTD) v4.0 DRAFT Implementation Guide v2.0; and eCTD Implementation Package DRAFT Specification for Submission Formats v2.0 April 2015

Final

 

Implementation of ICH M8
 
The ICH M8 Draft Implementation Guide has been updated and is now available for public comment [ Federal Register NOA]. The Draft Specification for Submission Formats document has also been produced that provides specifications for creating files. Comments are also invited for this document.
 
Draft document package available for comment
 
This Implementation Package comprises multiple documents and files. Note that these documents should be used in conjunction with the FDA Regional/Module 1 documents (available at Electronic Common Technical Document (eCTD) v4.0 .
 
The two main documents are (1) the ICH M8 Draft Implementation Guide, which provides instructions for creating the eCTD v4.0 Health Level 7 Regulated Product Submission (HL7 RPS) message for the ICH Modules 2 through 5 of the eCTD, and (2) the Draft Specifications for Submission Formats document, which provides specifications for creating files for inclusion in the eCTD. The Draft ICH Code List includes harmonized controlled vocabularies, and the M8 Genericode and Schema Files include a computable list of controlled vocabularies for eCTD v4.0. 
This draft document package is only for review and comment, and not for implementation. The Draft Implementation Guide and related documents are available for comment.
 
 
Reference document provided for information
 

 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.