M8 – 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).

The ICH Harmonised Guideline was finalised under Step 4 in July 1997. This document covers the preclinical safety testing requirements for biotechnological products. It addresses the use of animal models of disease, determination of when genotoxicity assays and carcinogenicity studies should be performed, and the impact of antibody formation on duration of toxicology studies.

An addendum was proposed to provide clarification on S6 and an update of the following topics discussed in the original ICH S6 Guideline: species selection, study design, immunogenicity, reproductive and developmental toxicity and assessment of carcinogenic potential. The Harmonised addendum provides further complementary guidance to the S6 Guideline and helps to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.

The addendum reached Step 4 of the harmonisation process in June 2011 and was integrated as part II in the core Guideline that was then renamed S6(R1).

M8 – Electronic Common Technical Document (eCTD)

Annexes

Annexes

Q+A