Ensuring compliance with the electronic submission guidelines set forth by the FDA and the PMDA for data submitted in a standardized CDISC format has become increasingly crucial. Currently, the task of submitting identical electronic data packages to both agencies poses certain challenges. However, understanding these regulatory requirements is essential for effectively planning, developing, and submitting study data deliverables. To shed light on this complex landscape, the presentation highlights both the similarities and differences between the FDA and PMDA guidelines for CDISC-standardized data submission. Following this comparative overview, the presentation offers a detailed analysis of specific PMDA requirements. Additionally, the presentation includes examples from two case studies that demonstrate the practical application of these guidelines and the challenges faced during package preparation. This approach aims to equip stakeholders with a comprehensive understanding of the regulatory landscape, facilitating smoother and more compliant submissions to both regulatory agencies.