Europe – Update : ICH guideline M4 (R4) on common technical document (CTD) for the registration of pharmaceuticals for human use – organisation of CTD – Step 5

Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on November 8, 2000, this guideline is recommended for adoption to the three regulatory parties to ICH

(Numbering and Section Headers have been edited for consistency and use in e-CTD as agreed at the Washington DC Meeting, September 11-12, 2002)

(The Annex: Granularity Document has been revised at the Steering Committee held in Osaka, November 11, 2003 and has been corrected on January 13, 2004 : The table for Module 2 has a row for 2.3.S.7 added)

(The Annex: Granularity Document has been adopted at the Assembly meeting on June 15, 2016 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)…