In 2003, the International Council on Harmonization (ICH) finalized guidance on marketing applications for drugs and biologics. Today, the Common Technical Document (CTD) format, recommended by ICH, is indispensable for marketing applications across various global jurisdictions, including mandatory use in regions such as Canada, Japan, Europe, and the U.S.A. Furthermore, the electronic Common Technical Document (eCTD) format has emerged as a necessity in key markets for electronic submissions, with mandatory adoption in several regions. Since January 2010, the European Medicines Agency mandated the use of eCTD for all applications in the centralized procedure, while in the U.S., following the 2012 reauthorization/update of the Prescription Drug User Fee Act (PDUFA), eCTD became obligatory for New Drug Applications, Biologics License Applications, and Abbreviated New Drug Applications. Additionally, the Generic Drug User Fee Act and Medical Device User Fee Act enforce mandatory electronic submissions to the FDA. This workshop offers participants a comprehensive overview of Health Canada’s guidance documents for preparing new Drug Submissions (NDS) encompassing Chemical drugs, biologicals, biopharmaceuticals, biosimilars, and chemical generics. Through analysis and discussion of significant areas such as Chemistry Manufacturing and Controls (CMC), Nonclinical, and Clinical aspects within the ICH CTD module format, attendees will gain insights and practical experience by working on a mock submission binder.