This document is a European Medicines Agency (EMA) publication, specifically from the Pharmacovigilance Risk Assessment Committee (PRAC). It details new safety information for several medicines, based on recommendations adopted in September 2025.
This document is an official guideline from the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). It provides a comprehensive framework for the management of safety signals for human medicines authorised in the European Union (EU).
This issue of New Zealand's Prescriber Update provides critical safety information and regulatory updates for healthcare professionals, 46(3) September 2025.
Vaccinovigilance is a specialized branch of pharmacovigilance focused exclusively on vaccines. The term is widely used, particularly in French-speaking countries and in international health contexts, and it is entirely synonymous with Vaccine Pharmacovigilance.
These are the official bodies in each country where you can report suspected side effects of medicines, vaccines, and quality issues.
Think of a new medicine as a new employee. For the first few years, you monitor them closely with frequent performance reviews. A PSUR/PBRER is like that comprehensive performance review for a medicine, looking at both its benefits (the good work it does) and its risks (its shortcomings or side effects) to decide if it...
The document "The use of the WHO-UMC system for standardised case causality assessment" provides a detailed explanation of the WHO-UMC causality assessment system, which is used in pharmacovigilance to evaluate the likelihood that a suspected adverse drug reaction (ADR) is actually caused by a drug.
Advancing Medication Safety Through Knowledge and Vigilance
