National Medical Products Administration,China NMPA and the National Center for Adverse Drug Reaction Monitoring released the National Adverse Drug Reaction Monitoring Annual Report (2025). The report was published on April 27, 2026, to reflect the overall status of adverse drug reaction (ADR) monitoring activities in China during 2025 and support medication safety. Chapter 1: […]
Spanish Agency of Medicines and Medical Devices (AEMPS) has released its Drug Safety Bulletin for December 2025, summarizing updated pharmacovigilance information for medicines marketed in Spain. The bulletin provides guidance for healthcare professionals, regulatory teams, and pharmaceutical companies on signal detection, risk management, and adverse drug reaction (ADR) reporting. (AEMPS Bulletin) Key Safety Updates […]
The Food and Drug Administration has placed major retail chains under regulatory scrutiny following inspections at their Bonifacio Global City branches. The inspections were led by FDA Director General Atty. Paolo Teston as part of the agency’s nationwide initiative to strengthen oversight of food and health products sold in retail stores and across distribution channels. […]
The European Medicines Agency (EMA) has recommended the withdrawal of all medicines containing the active substance levamisole from the European Union (EU) market. The recommendation follows a detailed review by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of levamisole medicines no longer outweigh their risks for treating parasitic worm infections. Levamisole, […]
A new study published in Drug Safety reveals significant limitations in commonly used anticholinergic burden (ACB) scales, showing they fail to fully capture real-world adverse drug reactions (ADRs) associated with anticholinergic medications. Researchers analyzed over 101,000 cases from the French National Pharmacovigilance Database (FPVD, 1985–2024) involving drugs scored highly on 22 ACB scales or belonging to relevant […]
A comprehensive pharmacovigilance study recently published in the Saudi Pharmaceutical Journal has provided critical real-world evidence regarding the association between three major antibiotic classes and the risk of drug eruptions. By analyzing data from the United States Food and Drug Administration (U.S. FDA) Adverse Event Reporting System (FAERS) from 2020 through the first quarter of […]
The FDA maintains a rigorous post-market surveillance system to protect public health through advanced Pharmacovigilance. Central to this is the FAERS (FDA Adverse Event Reporting System), a critical database used for Medical Monitoring and identifying potential Safety Signals associated with drugs and biologics. Also, FDA emphasized the importance of its quarterly reporting process, which is […]
An Expert Working Group (EWG) of the Commission on Human Medicines (CHM), advising the Medicines and Healthcare Products Regulatory Agency (MHRA), has completed an in‑depth review of how the risks of 28 antidepressant medicines are described in Patient Information Leaflets (PILs). The review focused on whether current leaflets clearly explain suicidal behaviors and sexual dysfunction […]
The U.S. Food and Drug Administration (FDA) has approved significant safety updates for Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for Duchenne muscular dystrophy (DMD). The updated labeling now carries a Boxed Warning, highlighting risks of severe liver injury, including fatal acute liver failure. The therapy’s indication is now restricted to ambulatory patients aged four and […]
Children and young adults, particularly university students, remain at risk from meningococcal meningitis and septicaemia, conditions that, while rare, can be devastating, life-changing, and sometimes fatal. Latest data from the UK Health Security Agency (UKHSA) reports 378 confirmed cases of invasive meningococcal disease (IMD) in 2024-25. MenB was the dominant strain, accounting for 82.6% (313 […]
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