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 August 2018)


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


Module 1 Information - CH (v.1.3)

MD5 checksum of v.1.3 ch-regional.dtd:  2cd4b7bc430f86d688eb935d46750ccc

MD5 checksum of v.1.3 ch-envelope.mod:  ec819ec0b949d6977617c77e696bd580

MD5 checksum of v.1.3 ch-leaf.mod:  ef515d814fdc5705f2379499c081919e

MD5 checksum of v.1.3 ch-regional.xsl:  ad05a96df76bb9463be69d67b78c73a8

EU 3.0.3

Module 1 Information - EU (V3.0.3) *technical files remain at v3.0.1 Updated

M1 v3.0.1 checksum for eu-regional.dtd is: 290503bf171e7e2e80ef90f0bde5d91e

M1 v3.0.1 checksum for eu-envelope.mod is: d0727ae0fb68b19edae49ab9e2e22a4a

M1 v3.0.1 checksum for eu-leaf.mod is: 23b854174e61c68044b9f53c0009af95

M1 v3.0.1 checksum for eu-regional.xsl is: 0107179c3739ebbd6b00ce492fe6e1e7


Web page


Direct link to M1 schema

MD5 checksum of M1 schema: cb985b998065f878421548e9a84bbd41

Direct link to XLINK schema

MD5 checksum of XLINK schema: affa55a3ba4dd67601a3318c437281e1


Module 1 Information - US (V1.3)

MD5 checksum of M1 DTD: 9d09aa5ffdb44368416e287f9b0ddeeb

Module 1 Information - US (V2.3) MD5 checksum of M1 DTD: bea39be6d3a1716262a30a87657bce2d

Change Control

Last updated: August, 2018