5 August 2016

The revised version of the ICH M4(R3) Guideline on the overall organisation of the CTD including the Granularity Document reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5).

The M4(R4) Guideline includes a revised version of the Granularity Document to add Module 2 and 3 tables and Appendices for eCTD v4, as well as, corrections to Module 2 and 3 tables for eCTD v3.2.2.

The M4(R4) is available for download under the Multidisciplinary/CTD Guideline page on the ICH website.