Module 1: Regional Administrative Information

Module 1 is the only region-specific module in the eCTD (electronic Common Technical Document) and ACTD (ASEAN Common Technical Document). It houses all administrative data, application forms, cover letters, prescribing information, and regulatory correspondence required by each authority. Because requirements differ across FDA, EMA, CDSCO, and ASEAN member states, mastery of Module 1 is critical to first-cycle acceptance of any marketing-authorization application.