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<p>The paradigm shift in pharmacovigilance from simple observation to active global data monitoring has presented opportunities and threats to the national regulatory authorities. This work tried to analyze the pharmacovigilance systems of the United States, the European Union, and India with an idea of their strategic differences and paths to modernization. Analysis revealed various developmental levels. The US FDA’s Sentinel Initiative signifies a really well-developed, distributed active surveillance model; while the EU’s system, through EudraVigilance, interfaces centralized spontaneous reporting with structured proactive studies. In contrast, India’s government initiative, the Pharmacovigilance Programme of India (PvPI), although rapidly growing, is largely passive, facing underreporting and infrastructure limitations. We have concluded that the future pharmacovigilance rests not on a single model but on a hybrid approach strategically incorporating real-world evidence (RWE) along with artificial intelligence (AI). It has proposed a transnational framework based on the following three pillars: AI-driven signal amplification for transitioning current systems, such as India’s, from passive data collection to active risk detection; an adaptive regulatory convergence for harmonization of standards while taking into account regional contexts; and interoperable data architecture to enable global collaboration. This work outlines very clear routes for converting active surveillance into passive-surveillance capacity and upgrading pharmacovigilance to the age of digitalization.</p>

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Elevating Drug Safety Oversight: A Comprehensive Examination of Dynamic and Static Monitoring Systems across the United States, European Union, and India

  • 期刊论文

  • 发表日期：

    2026年1月6日

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  • Deepika N,
  • Robin George,
  • Ravi Kumar Reddy Juturi,
  • Baharul Islam Haidary,
  • Prasiddhi Naik,
  • Prakash Goudanavar

摘要

The paradigm shift in pharmacovigilance from simple observation to active global data monitoring has presented opportunities and threats to the national regulatory authorities. This work tried to analyze the pharmacovigilance systems of the United States, the European Union, and India with an idea of their strategic differences and paths to modernization. Analysis revealed various developmental levels. The US FDA’s Sentinel Initiative signifies a really well-developed, distributed active surveillance model; while the EU’s system, through EudraVigilance, interfaces centralized spontaneous reporting with structured proactive studies. In contrast, India’s government initiative, the Pharmacovigilance Programme of India (PvPI), although rapidly growing, is largely passive, facing underreporting and infrastructure limitations. We have concluded that the future pharmacovigilance rests not on a single model but on a hybrid approach strategically incorporating real-world evidence (RWE) along with artificial intelligence (AI). It has proposed a transnational framework based on the following three pillars: AI-driven signal amplification for transitioning current systems, such as India’s, from passive data collection to active risk detection; an adaptive regulatory convergence for harmonization of standards while taking into account regional contexts; and interoperable data architecture to enable global collaboration. This work outlines very clear routes for converting active surveillance into passive-surveillance capacity and upgrading pharmacovigilance to the age of digitalization.