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). A zip compressed version is also provided. The zip file is password protected with the password "template".

Regional / Module 1 Information (added to this page January 6, 2009)

Region	Link to Module 1 Information	DTD/Schema Checksum if Available
CA	http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/ectd/dtd_module_1_let-eng.php	MD5 checksum of M1 DTD: 3d2ce6692d8727aa4cc9463b4ca18f00
EU	http://esubmission.emea.europa.eu/eumodule1/index.htm	M1 v1.3 checksum for eu-regional.dtd is: 12e5c2a5e901f336523fab644ca1a444
		M1 v1.3 checksum for eu-envelope.mod is: 465c4813362aca1073b9de94aff63e9c
		EU M1 v1.3 checksum for eu-leaf.mod is: 039bfb13f93442beda41e8e0030f8cf8
JP	Web page: http://www.pmda.go.jp/ich/m4.htm Direct link to M1 schema: http://www.pmda.go.jp/ich/m/eCTD/util/dtd/jp-regional-1-0.xsd	MD5 checksum of M1 schema: cb985b998065f878421548e9a84bbd41
	Direct link to XLINK schema: http://www.pmda.go.jp/ich/m/eCTD/util/dtd/xlink.xsd	MD5 checksum of XLINK schema: affa55a3ba4dd67601a3318c437281e1
US	www.fda.gov/cder/regulatory/ersr/ectd.htm	MD5 checksum of M1 DTD: 9d09aa5ffdb44368416e287f9b0ddeeb

Change Control