Standard form of a periodic safety update report

Abstract

The results of evaluating information in the Periodic safety update reports (PSUR) submitted by marketing-authorisation holder indicate a lack of understanding of regulatory requirements for the preparation of this document. As a result PSURs submitted by some marketing authorisation holders are returned to them for correction. The purpose of this article is to present the standard forms of PSUR, which will allow you to adequately prepare this reporting document.

Keywords

• периодический отчет по безопасности (поб)
• периодический обновляемый отчет по безопасности (пооб)
• периодический отчет по безопасности лекарственного средства (поблс)
• периодический отчет по безопасности лекарственного препарата (поблп)
• шаблон
• periodic safety update reports (psur)
• standard forms