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
- Docket Number:
- FDA-2013-S-0610
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
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This draft document package is only for review and comment, and not for implementation.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.
- M8 eCTD v4.0 DRAFT Implementation Guide v2.0 (PDF - 1,353KB)
- eCTD v4.0 Implementation Package DRAFT Specification for Submission Formats v2.0 (PDF - 145KB)
- Draft ICH Code List v2.0 (excel file - 66 KB)
- M8 Genericode and Schema Files (zip file 173 KB)
Reference document provided for information
- ICH eCTD v4.0 Requirements (last updated November 11, 2010)
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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 written comments should be identified with this document's docket number: FDA-2013-S-0610.