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In today’s global pharmaceutical landscape, Risk Management Plans (RMPs) are cornerstone documents ensuring that the benefits of medicinal products outweigh their risks. They serve…

In pharmacovigilance, Local Safety Databases (LSDs) are critical for ensuring continuous monitoring of drug safety within specific countries or regions. While the WHO’s VigiBase…

Pharmacovigilance (PV) in China refers to the scientific and regulatory activities related to the detection, assessment, understanding, and prevention of adverse effects or any other…

PV Requirements in Latin American Countries (Brazil, Mexico, Argentina, Chile, and Colombia) Introduction Medicines don’t stop being monitored once they’re approved—they enter a new phase…

The Pharmacovigilance System Master File (PSMF) serves as a cornerstone document within pharmacovigilance systems, providing a detailed overview of a company’s PV activities and…

In Greece, pharmacovigilance (PV) activities are regulated and supervised by the National Organization for Medicines (EOF – Εθνικός Οργανισμός Φαρμάκων). The requirements are aligned with…

Modern pharmacovigilance monitors the safety of medicines throughout their life‑cycle and is essential for protecting public health. Safety signal detection refers to identifying patterns…

Although Australia and New Zealand are geographically close-to the point mistakenly considered to be one country-their pharmacovigilance (PV) systems are governed by different frameworks and…

In the pharmaceutical world, ensuring patient safety is a global priority, and the Qualified Person for Pharmacovigilance (QPPV) plays a central role in this mission.…

Pharmacoeconomics is rapidly becoming a cornerstone of healthcare decision-making in Saudi Arabia. With the release of the Saudi Food and Drug Authority (SFDA) guidelines on…