In an increasingly interconnected global pharmaceutical landscape, the electronic Common Technical Document (eCTD) has emerged as the standard format for regulatory submissions. However, navigating the intricacies of eCTD submissions in different regions remains a formidable challenge for pharmaceutical companies. This whitepaper delves into a comparative analysis of eCTD regulatory submissions in the United States and China. By dissecting the key distinctions and convergences in these regulatory processes, this document aims to equip drug manufacturers with the knowledge required to effectively manage the complexities of international drug development and regulatory compliance.
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