ICH eCTD v4.0 Draft Implementation Guide v2.0

By 27. February 2015Blog

At the ICH M8 EWG meeting in November 2014, the Steering Committee endorsed the M8 EWG to post the ICH eCTD v4.0 DRAFT Implementation Guide v2.0 and related files for regulatory consultation. These documents are now available for regulatory consultation until May 22, 2015 and can be accessed using the following link:

http://estri.ich.org/new-eCTD/index.htm

The most detail in this update is given to the following:

  • Fonts – allows for embedding of a subset of Japanese fonts (only those used within the document) rather than the full set
  • Methods for Creating PDF Document and Images – specifies resolution criteria for various types of documents
  • SVG – identifies this language for describing two-dimensional graphics in XML and states that its use in a submission should be discussed with the respective regulatory authority.

Comments on the documents enclosed in the Implementation Package may be submitted to the ICH Secretariat at: Step2comments@ich.org. It is expected that the comments will be considered and implemented in Q3 2015 with sign-off in late 2015.

It looks like we are still on track for implementation in 2016. Stay tuned…