Periodic safety reports are prepared as a part of periodic adverse experience submission. It is an unceasing cycle till the product’s lifespan in market is anticipated. With emergence of changing risk-benefit ratio, the reporting period may change if regulatory needs more information for monitoring a pharmaceutical product.
Considering the United States requirements for periodic reports, there are four sections in accordance to which the format should be reported. The emphasis is placed to prepare checklist (Appendix B: Report checklist1) and ensure that all the data requested in those sections is available for final periodic report.