| 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 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 November 2012)
Region |
Link
to Module 1 Information |
DTD/Schema
Checksum if Available |
| CA 1.0 | Module 1 Information - CA (V1.0) | MD5 checksum of M1 DTD: 3d2ce6692d8727aa4cc9463b4ca18f00 |
| 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 1.4.1 | Module 1 Information - EU (V1.4) | M1 v1.4 checksum for eu-regional.dtd is: 91654e96e3bafc5e89df7f892477b246 |
| M1 v1.4 checksum for eu-envelope.mod is: 664a76e3f31a9553d3375d3b21815904 | ||
| M1 v1.4 checksum for eu-leaf.mod is: 2e976bc60658a964affa5026369a371e | ||
| 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 | MD5 checksum of M1 DTD: 9d09aa5ffdb44368416e287f9b0ddeeb |
Change Control
(zipped MS Excel
spreadsheet)