UNIT 5: Global Pharmacovigilance and Regulatory
This unit explains how Pharmacovigilance is regulated and implemented globally, describing the role of international organizations, national regulatory authorities, and harmonized guidelines. It provides a clear understanding of how safety data flows from reporters to regulators and how global alignment ensures consistent patient safety standards.
Pharmacovigilance operates within a global framework designed to protect patients by ensuring the continuous monitoring of medicine safety across countries. Since medicines are developed, manufactured, and marketed internationally, safety data generated in one country can have implications worldwide. A coordinated global pharmacovigilance system allows early detection of safety issues and timely regulatory action across regions.
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