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 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.
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).
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.
Major global health organizations, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO), do not recognize autism as a known adverse drug reaction (ADR) of paracetamol. Review of Studies The controversy largely stems from observational studies (not clinical trials) that suggested a potential association between prenatal exposure to paracetamol and a slightly...
The newsletter is structured into three main sections, each containing crucial safety information: 1. Regulatory Matters This section details specific regulatory actions taken by authorities worldwide concerning various medicinal products. 2. Safety of Medicinal Products This section provides important safety reminders and new information on specific drugs. 3. Feature: Key Recommendations from WHO...
The newsletter is structured into three core sections, each highlighting significant safety and regulatory developments. 1. Regulatory Matters This section details specific regulatory actions and safety reviews undertaken by national health authorities. 2. Safety of Medicinal Products This section provides important safety communications and updates on potential risks. 3. Feature: WHO Global Smart...
Advancing Medication Safety Through Knowledge and Vigilance
