March 4, 2026
With over 6,000 identified rare diseases and millions of medical devices in daily use worldwide, standardized adverse event reporting is critical for public health safety.
With over 6,000 identified rare diseases and millions of medical devices in daily use worldwide, standardized adverse event reporting is critical for public health safety.
Version 29.0, released in March 2026, introduces significant terminology updates, including new terms, revised hierarchies, changes to Standardised MedDRA Queries (SMQs), and important modifications to medication error concepts.
This article provides a comprehensive medical overview of rare diseases, with a dual focus: first, on drug-induced rare diseases as adverse reactions, and second, on the critical risk-benefit calculus for therapies where the treatment's side effects may be as severe as the disease itself.
From a pharmacovigilance standpoint, Ramadan represents a period of systematic medication schedule disruption, altered drug pharmacokinetics, and increased vulnerability to adverse drug reactions (ADRs).
Significant label update regarding mesalazine and idiopathic intracranial hypertension, a detailed local case report on warfarin-food interaction leading to ischemic stroke
At its January 2026 meeting, PRAC adopted important new safety information concerning three distinct medicinal products: cefazolin (and cefazolin with lidocaine), erdatinib, and pegylated liposomal doxorubicin.
Based on the EMA Guideline on Good Pharmacovigilance Practices (GVP) Chapter P.III – Product- or Population-Specific Considerations III
Advancing Medication Safety Through Knowledge and Vigilance
