A Study on the Preparation, Submission, and Regulatory Review of Electronic Common Technical Documents (eCTD) for Global Markets

Abstract

This study examined the preparation, submission, and regulatory review of electronic Common Technical Documents (eCTD) across global markets. The findings highlight that while the CTD and eCTD frameworks (ICH M4 and M8) have significantly advanced global harmonization, substantial regional differences in Module 1 requirements remain. These variations often result in duplication of work and increased resource requirements for multinational pharmaceutical companies. The comparative analysis of eCTD requirements across regulatory authorities (USFDA, EMA, PMDA, Health Canada, and CDSCO) revealed both convergence and divergence in dossier preparation and review. Modules 2–5 follow ICH standards consistently, ensuring that quality, non-clinical, and clinical data remain uniform. However, Module 1 demonstrates significant regional variation, leading to additional workload for companies pursuing global submissions. For instance, USFDA requires patent certification data, EMA emphasizes country-specific annexes, and PMDA requires Japanese translations. These differences, though regionally justified, reduce the harmonization that eCTD was intended to promote. Moreover, technical validation requirements especially XML granularity and hyperlinking—vary slightly, further complicating multinational submissions. Thus, the similarities facilitate a shared foundation for global submissions, but the differences create duplication, potential delays, and higher compliance costs.