M8 Electronic Common Technical Document (eCTD)
M8 eCTD v3.2.2 Electronic Common Technical Document (eCTD) v3.2.2
The Implementation Guide and related documents for the ICH M8 electronic Common Technical Document (eCTD) v3.2.2 can be found on the ESTRI page.
Date of Step 4: 1 July 2008
Status: Step 5
Related Links
M8 eCTD v4.0 Electronic Common Technical Document (eCTD) v4.0
The ICH M8 electronic Common Technical Document (eCTD) v4.0 is maintained by the M8 EWG/IWG. The Implementation Guide and related documents can be found on the ESTRI page.
Date of Step 4:
10 December 2015
Status: Step 5
M8 EWG/IWG Electronic Common Technical Document (eCTD)
ICH M8 EWG was formed in November 2010 to take over the development and revision of eCTD v4.0 Implementation Guide and related documents from the ICH M2 eCTD Subgroup. The eCTD v4.0 requirements were addressed by the Standard Development Organisation process and are included in the Health Level Seven Version 3 Regulated Product Submission Release 2 Normative standard. At the ICH Jacksonville meeting in December 2015, the ICH eCTD v4.0 Implementation Package v1.0 and Specification for Submission Formats for eCTD v1.0 was signed off for Step 4 by the Assembly. The package was updated to v1.1 to incorporate minor edits before being published. While the v4.0 is the latest version of the eCTD, v3.2.2, originally released by ICH in July 2008, is still made available in view of time needed for users to transition to the updated version.
The M8 EWG also provides technical review and impact assessment of issues arising from the use of the ICH M4 CTD Guidelines within the context of the eCTD. This activity includes an update of M4 Annex: Granularity Document in accordance with the agreement by appropriate M4 Working Group whereas the Granularity Document continues to be owned by M4.
ICH M8 IWG was established in conjunction with the formation of M8 EWG in November 2010, and assumed the responsibility for the implementation and maintenance of eCTD and Study Tagging File specifications from the ICH M2 eCTD Subgroup. The IWG is also responsible for implementation and maintenance of other M8 EWG deliverables (e.g. Specification for Submission Format for eCTD).
Date of Step 4: 6 August 2018
Status: Step 5
Endorsed Documents (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
