Journal of Pharmacovigilance and Quality Assurance ISSN: 3108-2343 (Online)

Authors: Pakanikar Satish Limbaji, Vinod Shirke

Abstract: Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, plays a crucial role in ensuring the safety of pharmaceutical products worldwide. In recent years, there has been a growing recognition of the need for global harmonization of pharmacovigilance regulations to enhance efficiency, consistency, and patient safety. This paper explores the challenges and opportunities associated with achieving global harmonization in pharmacovigilance, with a focus on regulatory frameworks and the potential benefits for public health.

Keywords: Pharmacovigilance, Global harmonization, Regulatory frameworks, Adverse drug reactions. Patient safety, Drug safety, International collaboration, Regulatory convergence, Risk communication, Capacity building.