Aggregate safety reports represent a significant aspect of the Japanese pharmacovigilance landscape, providing a structured and comprehensive assessment of a drug's evolving safety profile by integrating global and domestic clinical trial and post-marketing data. Principles set out in the International Council for Harmonisation guidelines can be applied for the preparation of Japan-specific aggregate reports such as the development safety update report and periodic benefit-risk evaluation report; however, these reports should also incorporate elements specific to the clinical and post-marketing experience in Japan. The Japanese pharmacovigilance legislation further necessitates the preparation of post-approval aggregate reports such as non-serious unexpected periodic reports, infection periodic reports, and early post-marketing phase vigilance reports. Sponsors of clinical trials and marketing authorisation holders in Japan should ensure compliance with the current legislation to effectively evaluate the safety of their products whilst fulfilling their regulatory obligations for aggregate safety report preparation and submission.