Regulatory Authority in Pharmacovigilance

Abstract

Abstract: Based on their Gross National Income (GNI) per capita, the World Bank has categorized 80 economies as HighIncome. Global pharmacovigilance rules are primarily driven by three major regulatory stakeholders: the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA). This article's goal is to provide an overview of pharmacovigilance systems and procedures in high-income nations, especially those that are also International Conference on Harmonization (ICH) members. Every high-income nation is a part of the WHO PIDM. Medication safety precautions are directly correlated with a nation's income level. The 10 intrepid members of the Uppsala Monitoring Center are from affluent nations and were among the first to act following the thalidomide catastrophe, establishing drug appraisal committees, launching ADR reporting forms, and implementing safety protocols. Although VigiBase is accessible, several nations have their own databases for data management and analysis, such as the FDA Adverse Event Reporting System, the French pharmacovigilance database, the EU's Eudravigilance system, and Canada's Vigilance online database. Strong pharmacovigilance systems are present in all high-income nations. The two international leaders in pharmacovigilance are the USFDA and EMA. The majority of wealthy nations adhere to EMA regulations. The degree of affluence in a nation directly affects the safety of medicines.