Tag: Regulatory reporting

Over 7,500 organizations use MedDRA, and thousands more rely on WHODrug, highlighting the widespread need for standardized medical and drug terminology. While both are essential tools in clinical research and pharmacovigilance, knowing what is the difference between MedDRA and Whodrug is crucial, as they serve entirely different, yet complementary, functions.

According to the European Medicines Agency (EMA), pharmacovigilance documents like PSUR and ICSR are fundamental to monitoring drug safety throughout its lifecycle. This article clarifies **what is the difference between PSUR and ICSR**, detailing their distinct roles and purposes in safeguarding public health.

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.

A valid Individual Case Safety Report (ICSR) must contain at least four core elements: an identifiable patient, an identifiable reporter, a suspect drug, and an adverse event. So, what is ICSR in pharmacovigilance and why is this standardized report so critical for patient safety and regulatory oversight?