This document is an official release note from the Maintenance and Support Services Organization (MSSO) detailing the changes and updates introduced in MedDRA (Medical Dictionary for Regulatory Activities) Version 28.1, released in September 2025. MedDRA is a standardized medical terminology used for regulatory communication and data analysis in the healthcare industry.
In the complex, globalized world of pharmaceuticals, clear communication is a matter of patient safety. MedDRA (the Medical Dictionary for Regulatory Activities) is the critical, standardized terminology that ensures a "heart attack" in a report from Japan is understood identically by a regulator in Europe. This article explores how this universal language powers...
Imagine a patient harmed by a medication error. The old approach asked, "Who is to blame?" The modern approach, fueled by pharmacovigilance, asks, "Why did our system allow this to happen?" This article explores the critical, data-driven partnership between pharmacovigilance and patient safety that is transforming healthcare from a culture of blame to...
Your genes provide the instructions for making proteins, and many of these proteins are involved in how your body handles and responds to medicines. Genetic differences (variations) can lead to differences in these proteins, which in turn affect your response to a drug.
This document, published by the European Medicines Agency (EMA) in 2015, provides comprehensive regulatory guidance for the pharmaceutical industry and national competent authorities on minimizing and preventing medication errors throughout a medicinal product's life-cycle.
This document provides expert recommendations for healthcare professionals on how to diagnose, manage, and understand liver injury caused by prescription drugs, herbal products, and dietary supplements (HDS). It is called a "guidance" instead of a "guideline" because there are very few high-quality randomized controlled trials on this topic; the recommendations are based on...
This document is a Direct Healthcare Professional Communication (DHPC) issued in August 2025 by a Marketing Authorization Holder (MAH) in agreement with the Egyptian Drug Authority. Its primary purpose is to communicate a critical safety warning regarding the use of the diabetes medication Metformin in patients with specific mitochondrial diseases.
Advancing Medication Safety Through Knowledge and Vigilance
