ACTD vs CTD Format: Comprehensive Guide to Global and Regional Dossier Strategies ACTD vs CTD Explained: Compliance-Ready Guide for Dossier Preparation Introduction to ACTD and CTD Formats The Common Technical Document (CTD) and the ASEAN Common Technical Dossier (ACTD) are two of the most widely recognized formats for regulatory submissions worldwide. The CTD, developed by the International Council for Harmonisation (ICH), has become the global gold standard, mandated by major agencies including the FDA, EMA, PMDA, and Health Canada. In contrast, the ACTD is specific to the ASEAN region, harmonizing dossier submissions across ten Southeast Asian member states. Understanding the…