Category: Pharmacovigilance

Over 100 countries now use the Medical Dictionary for Regulatory Activities (MedDRA) to report and analyze adverse event data for medical products. The primary purpose of MedDRA is to provide a single, universal standard for medical terminology, harmonizing communication across the global pharmaceutical industry, health authorities, and other stakeholders.

MedDRA, or the Medical Dictionary for Regulatory Activities, was developed by the International Council for Harmonisation (ICH) to facilitate the global sharing of regulatory information for medical products. In the context of pharmacovigilance (PV), understanding what is MedDRA in PV is crucial for anyone involved in reporting, analyzing, and monitoring the safety of medicines worldwide.

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.

Used by nearly 7,500 organizations in almost 130 countries, the Medical Dictionary for Regulatory Activities (MedDRA) is the international standard for coding medical information. This critical tool defines what is MedDRA in pharmacovigilance and ensures a consistent language for safety data reporting and analysis globally. By standardizing terminology, MedDRA facilitates the exchange of regulatory information among health authorities, pharmaceutical companies, and other stakeholders.

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?