A Complete Guide to eCTD and Electronic Submissions in Regulatory Affairs Mastering eCTD and Digital Regulatory Submissions for Pharma Approvals Understanding the Shift to eCTD in Regulatory Submissions The pharmaceutical industry has transitioned rapidly from paper-based submissions to digital formats like the electronic Common Technical Document (eCTD). This shift streamlines global regulatory processes, supports lifecycle management, and aligns with digital transformation trends across agencies. Originally developed by the International Council for Harmonisation (ICH), the eCTD format is now mandated by major health authorities such as the FDA, EMA, Health Canada, TGA, and PMDA. The eCTD facilitates structured, hyperlinked, and searchable…