
This document is the September 2025 newsletter (Volume 19, Issue 9) from the Egyptian Pharmacovigilance Center (EPVC).

This document is the September 2025 newsletter (Volume 19, Issue 9) from the Egyptian Pharmacovigilance Center (EPVC).

This document is the official Egyptian guideline for the Medical Device Vigilance System. Issued by the Egyptian Drug Authority (EDA), it establishes the mandatory framework for monitoring the safety and performance of medical devices after they have been approved and are being used in the Egyptian market. Its primary goal is to protect patient and user health by...

What Does "Back to Natural, Be Sustainable" Really Mean? This is a profound and complex topic that sits at the intersection of public desire, environmental science, and rigorous medical practice. Let's break it down in detail within the requested framework.

The traditional pharmacovigilance paradigm is centered on detecting adverse drug reactions (ADRs)—harmful and unintended responses to a drug used at normal doses. AMR, however, represents a reduction in a drug's intended clinical benefit. This fundamental shift—from monitoring safety to monitoring efficacy failure due to resistance—requires a significant evolution in PV practices.

The "Think D8" is a mnemonic tool introduced in the WHO AWaRe Antibiotic Book. It is designed to be a mental checklist for healthcare providers to run through before prescribing any antibiotic. Its goal is to ensure a deliberate, rational, and safe approach to antibiotic use, thereby combating antimicrobial resistance (AMR) and protecting patients.

This document is a comprehensive guide published by the World Health Organization (WHO) in 2022. Its primary purpose is to provide simple, evidence-based guidance on the use of antibiotics for common infections in both adults and children. The book is designed as a practical tool to improve antibiotic prescribing globally and to combat...

This document is the Draft Guideline for Veterinary Good Pharmacovigilance Practices in Egypt (VGVP). It is a comprehensive regulatory framework issued by the Egyptian Drug Authority (EDA), specifically through its Central Administration for Pharmaceutical Care and General Administration for Pharmaceutical Vigilance.
Advancing Medication Safety Through Knowledge and Vigilance