by Admin | Mar 13, 2026 | Safety Signals
In February 2026, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded its safety review of levamisole-containing medicines and recommended that their marketing authorisations be withdrawn from the EU market. EMA said the review...
by Admin | Mar 13, 2026 | Explainers
For pharmacovigilance professionals working in or around the European regulatory environment, PRAC safety signals are among the most important routine outputs to watch. The European Medicines Agency explains that, after each month’s Pharmacovigilance Risk Assessment...
by Admin | Mar 13, 2026 | Safety Signals
The Pan American Health Organization has called for strengthened pharmacovigilance following reports of misuse involving GLP-1 medicines indicated for treating obesity in adults. PAHO published the warning on 3 March 2026, placing additional public-health and...
by Admin | Mar 13, 2026 | Regulatory Updates
The UK’s updated clinical trials regulations will come into force on 28 April 2026, marking an important date for sponsors, researchers, and pharmacovigilance teams involved in CTIMPs. The Health Research Authority says the changes were developed after a 2022 public...
by Admin | Mar 13, 2026 | Regulatory Updates
The U.S. Food and Drug Administration has launched the FDA Adverse Event Monitoring System (AEMS), a new unified platform designed to modernize how adverse event reports are collected, analyzed, and accessed. According to the FDA, the system brings together reporting...