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.
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This draft document package is only for review and comment, and not for implementation.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.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.