On February 19, 2015, the ICH M8 electronic Common Technical Implementation Guide (eCTD IG) reached step 2b of the International Conference on Harmonization (ICH) process1. Pursuant to the process a draft technical document was issued. This document provides instructions on how to implement the eCTD v4.0 specification for Modules 2 through 5. The eCTD v4.0 would be a major change since v3.0 which was adapted in 2003 (currently in use specification is v3.2.2).
The goal of upgrading to eCTD v4.0 is to facilitate the processing and review of electronic regulatory submissions. During the regulatory review process as information is submitted, usually in increments, it is difficult to efficiently process and review new information in light of pre-existing information.
Major implementations for version4.0 of eCTD include:
- Document Reuse
- Document and Metadata life cycle
- Management of Document Groups
For further information a draft IG package can be downloaded from ICH eCTD v4.0 step 2
Comments on this draft are open by e-mailing the ICH Secretariat until May 22, 2015.
- For further information on Formal ICH procedure for implementation of a document can be found here – http://www.ich.org/about/process-of-harmonisation/formalproc.html