eCTD Specification and Related Files  
     
     
Electronic Common Technical Document Specification V3.2.2 (PDF)    

This specification has been developed by the ICH M2 Expert Working Group and maintained by the eCTD Implementation Working Group in accordance with the ICH Process as pertains to the M2 EWG and eCTD change control as it pertains to the eCTD IWG.

The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator. While the table of contents is consistent with the harmonised CTD, the eCTD also provides a harmonised technical solution to implementing the CTD electronically. This group has developed and begun to implement the eCTD across the ICH partner and observer regions. The group has developed a change control process to monitor implementation progress and provide solutions and added flexibility found necessary during implementation. Using the change control process, several topics including study report structure, lifecycle management, and consistency with the CTD are being addressed and resolved. This defined change control process ensures that the future of the eCTD is managed in a clear, harmonised manner within the ICH process.

The eCTD Specification is based on XML technology. The specification for the XML structure is the DTD. To ensure that the DTD has remained unchanged, use a tool to generate and compare the MD5 checksum of your copy with this MD5 checksum. An example of such a tool is WinMD5 (executable for MS Windows). See Readme.txt for installation instructions. The checksum for the eCTD DTD is: 1d6f631cc6b6357f0f4fe378e5f79a27

The M2 (ESTRI) Expert Working Group has provided a common stylesheet (Updated in November 2004) as referenced in eCTD Specification, to utilize, save locally and contact your technical support for instruction. To ensure that the stylesheet has remained unchanged, use a tool to generate and compare the MD5 checksum of your copy with this MD5 checksum. The checksum for the eCTD stylesheet is: 3a07a202455e954a2eb203c5bb443f77

An empty folder structure can be created using this executable program (for Windows only). The zip file is password protected with the password "template".

 

Regional / Module 1 Information (current as of June 2014)

Region
Link to Module 1 Information
DTD/Schema Checksum if Available
CA 2.2 Module 1 Information - CA (V2.2)

MD5 checksum of ca-regional-2-2.xsd: ff564d6e69adebd9a9b4f274e65cf5f1

MD5 checksum of xlink.xsd: 52d1a3b8596e4fb61d3ec1cde24be16a
MD5 checksum of xml.xsd: 382b0a4f7529d2c5f7b0af0aa713b0a5
EU 2.0 Module 1 Information - EU (V2.0) M1 v2.0 checksum for eu-regional.dtd is: 9dc9debb051a9e5762fc19a1f55132da
M1 v2.0 checksum for eu-envelope.mod is: 0ebe02fcdff7e40eff94a88074ca217a
M1 v2.0 checksum for eu-leaf.mod is: 23b854174e61c68044b9f53c0009af95
M1 v2.0 checksum for eu-regional.xsl is: bf40b657579356c7b4d6c866625d8171
JP  Web page  
Direct link to M1 schema MD5 checksum of M1 schema: cb985b998065f878421548e9a84bbd41
Direct link to XLINK schema MD5 checksum of XLINK schema: affa55a3ba4dd67601a3318c437281e1
US

Module 1 Information - US

MD5 checksum of M1 DTD: 9d09aa5ffdb44368416e287f9b0ddeeb

Change Control

 
Last updated: June, 2014