Comprehensive analysis of the MedDRA Version 29.0 IME list, including newly added terms, demoted terms, primary SOC changes, and the clinical significance of key updates. A comparative analysis with Version 28.1 highlights the evolution of this essential regulatory tool.
ATMPs are dynamic, often patient‑specific, and designed to achieve durable or even curative effects through permanent genetic modification, cellular engraftment, or tissue regeneration.
It occurs when patients experience adverse symptoms solely because they expect them, rather than due to the pharmacological action of a drug.
New aspect of a known risk (aseptic meningitis in healthy young adults following live attenuated chikungunya vaccination), a new adverse reaction for an established acetylcholinesterase inhibitor (nightmares with galantamine), and a request for supplementary information on the increased risk of ectopic pregnancy with lower-dose levonorgestrel intrauterine devices (13.5 mg).
A label update from the New Zealand regulatory authority (Medsafe) regarding Pisa syndrome associated with donepezil and other medicines. Two local Individual Case Safety Reports (ICSRs) of urinary incontinence following isotretinoin use, with a positive rechallenge in one case.
This article provides a detailed medical and scientific overview of VigiBase, based on the 2026 resource profile update published by UMC researchers. It covers the database’s history, data collection and processing workflows, coding standards (WHODrug Global and MedDRA), analytical tools (including vigiMatch, vigiGrade, vigiRank, and the VigiBase pregnancy algorithm), and key descriptive statistics....
The European Medicines Agency (EMA), through its Committee for Veterinary Medicinal Products (CVMP), has established comprehensive guidance for risk management plans (RMPs) for novel therapy veterinary medicinal products (NT-VMPs).
Advancing Medication Safety Through Knowledge and Vigilance
