Tag: Ich

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.

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.