Tag: Adverse event reporting

According to the National Institutes of Health (NIH), a valid Individual Case Safety Report (ICSR) must contain four minimum criteria to be reportable to regulatory bodies. This critical component of pharmacovigilance is designed to monitor drug safety by identifying and reporting adverse drug reactions and is centered around understanding what are the 4 elements of ICSR.

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.