February 15, 2026
Medical overview of childhood cancer, with special emphasis on drug-induced adverse reactions, including the rarely discussed topic of therapy-related secondary cancers, and their management from a pharmacovigilance perspective.
Medical overview of childhood cancer, with special emphasis on drug-induced adverse reactions, including the rarely discussed topic of therapy-related secondary cancers, and their management from a pharmacovigilance perspective.
From a pharmacovigilance standpoint, drug-induced anaemia is a significant and often under-recognized adverse drug reaction (ADR). It can occur through various mechanisms, and early detection is crucial to prevent morbidity and mortality.
The Egyptian Drug Authority (EDA) has established a structured framework for managing variations to pharmaceutical products in the post-marketing phase. The document titled Administrative & Relevant Documents & Time frame for human pharmaceutical variations (Version 1/2026, Code NP. CAPP.109) serves as a critical guideline for applicants seeking to modify registered medicinal products.
New Zealand's Medsafe provides clear guidelines outlining the responsibilities and processes for ensuring participant safety during clinical investigations of both medicines and medical devices.
The signals include a new safety concern for Kounis syndrome with cefazolin and epiphysiolysis with erdafitinib and a rare renal adverse event with pegylated liposomal doxorubicin. In addition, PRAC requested supplementary information for several other signals, including strabismus with atropine eye drops, angioedema with darolutamide, DRESS syndrome with oxacillin, acute pancreatitis with vortioxetine,...
This is the 19th volume, 12th issue of the EPVC’s monthly newsletter, published in December 2025. It serves as an official communication from the Egyptian Drug Authority (EDA) to healthcare professionals, regulators, and the public regarding drug safety, pharmacovigilance activities, and regulatory updates in Egypt.
By integrating Directed Acyclic Graphs (DAGs) from causal inference into pharmacovigilance practice, the authors provide a structured way to map, understand, and mitigate the biases that have long plagued signal detection.
Advancing Medication Safety Through Knowledge and Vigilance
