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eCTD

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 November 29, 2011) Region Link to Module 1 Information Module 1 Information - CA DTD/Schema Checksum if Available MD5 checksum of M1 DTD: 3d2ce6692d8727aa4cc9463b4ca18f00 M1 v1.4 checksum for eu-regional.dtd is: 91654e96e3bafc5e89df7f892477b246 M1 v1.4 checksum for euenvelope.mod is: 664a76e3f31a9553d3375d3b21815904 M1 v1.4 checksum for eu-leaf.mod is: 2e976bc60658a964affa5026369a371e M1 v1.3 checksum for eu-regional.dtd is: 12e5c2a5e901f336523fab644ca1a444 Module 1
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CA

EU 1.4

Module 1 Information - EU (V1.4)

M1 v1.3 checksum for eu1/2

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eCTD

EU V1.3 Information - EU (V1.3)

envelope.mod is: 465c4813362aca1073b9de94aff63e9c M1 v1.3 checksum for eu-leaf.mod is: 039bfb13f93442beda41e8e0030f8cf8

Web page JP Direct link to MD5 checksum of M1 schema: M1 schema cb985b998065f878421548e9a84bbd41 Direct link to MD5 checksum of XLINK schema: XLINK affa55a3ba4dd67601a3318c437281e1 schema US Module 1 Information - US MD5 checksum of M1 DTD: 9d09aa5ffdb44368416e287f9b0ddeeb

Change Control The eCTD IWG has implemented a Change Control Process. (MS Word document) A request for change may be submitted by use of this form. (RTF file) Results of change requests are published in the Q&A document spreadsheet) Last updated: November 29, 2011 (MS Excel

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