ICH eCTD v4.0 Step 4 page  

Background
The ICH M2 EWG has previously developed a list of requirements for input into the Health Level Seven (HL7) Regulated Product Submissions (RPS) Project. The list of requirements was last updated on November 11, 2010, and a link is available below on this page to use as a reference.

The ICH M8 EWG was formed in November 2010 to assume responsibility for the continued development of the next major version of the eCTD.

At the December 2015 ICH meeting, the ICH Assembly endorsed the Step 4 ICH eCTD v4.0 Implementation Package v1.0 and related files. Editorial minor updates were made to the Package and a minor version was added (v1.1).

The Package has been updated in response to the change requests and/or discussion within the EWG after its initial release. See the Implementation Package History document enclosed in the Package for details. The latest version (v1.2) was endorsed by the ICH Assembly at the November 2016 ICH meeting.

ICH Step 4  
ICH Step 4 is an ICH step where the ICH Assembly agrees that there is sufficient consensus on the Guideline.

Step 4 Implementation Package 
To download the package, click here.

This Implementation Package comprises multiple documents and files. Note that these documents need to be used in conjunction with the Regional/Module 1 documents provided on each of the regional consultation pages (see links below).

Document

File Name

Version Number

Description

ICH eCTD v4.0 Implementation Package History v1.2 eCTD v4_0_Implementation_Package_History_v1_2.pdf V1.2 History of the documents and files contained in the Implementation package.

ICH eCTD v4.0 Implementation Guide

ICH_eCTDv4_0_ImplementationGuide_v1_2.pdf

V1.2

Instructions for the harmonized portions of the eCTD v4.0 message specification

ICH Code List for eCTD 4.0

ICH_eCTDv4_0_CVv2.xlsx

V2.0

Harmonized controlled vocabularies

ICH Code List for Transition Mapping Message

ICH_eCTDv3_2_2TMM_CVv2.xlsx

V2.0

Harmonized controlled vocabularies

M8 Genericode Schema and Files

Genericode

-

Folder containing a computable list of controlled vocabularies

Schema Files for eCTD v4.0 Message ICH_eCTD_v4_SchemaFiles - Folder containing a harmonized set of schema files

Supplemental Documents for eCTD v4.0 Implementation Package
The following documents are to facilitate understanding of the Implementation Package:

Schema Files for eCTD v4.0 message
The Implementation Package above contains the schema files for eCTD v4.0 Step 4. Implementers should use the included schema files. 

Extract the zip file to a convenient location. The folder/file structure found in the zip file is important. When referencing these schema files with software tools, the 2 folders ("coreschemas" and "schema") along with the schema files within those folders should be maintained.

Regional pages
EU regional implementation page
JP regional implementation page (under construction)
US regional implementation page
CH regional implementation page (under construction)
CA regional implementation page (under construction)

Additional documents (for reference)

Change Control

 

Last updated: January 2017