Tag: Ich guidelines

The PBRER submission schedule is not a single, fixed timeline but varies based on factors like a drug's lifecycle, with new products requiring more frequent reports initially before transitioning to less frequent intervals. This variable reporting frequency is a cornerstone of modern pharmacovigilance and directly addresses the question of **How often is PBRer submitted?**.

According to the International Council for Harmonisation (ICH), aggregate safety reports provide a systematic, periodic collection and synthesis of safety information. Understanding the difference between Pbrer and Dsur is therefore critical for pharmaceutical sponsors, as these documents serve distinct purposes during different phases of a drug’s lifecycle. This guide delves into the specific roles, timing, and content of each regulatory filing.