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New Innovation and Idea | Pharmacology Science | Volume 15 Issue 4, April 2026 | Pages: 1260 - 1269 | India
Pharmacovigilance Maturity Assessment for High-Impact Business Scenarios: A GVP / ICH-Aligned Framework
Abstract: Pharmacovigilance (PV) organizations are operating in an increasingly complex environment driven by evolving global regulations, diverse data sources (including real world evidence and digital channels), and more distributed operating models. As a result, PV maturity has become a strategic requirement?not only to demonstrate compliance, but to ensure resilient end to end safety oversight, data integrity, and timely benefit?risk decision making. This whitepaper proposes an industry focused, corporate PV maturity assessment framework to support high impact scenarios such as mergers and acquisitions, licensing and partnerships, geographic expansion, outsourcing/vendor transitions, and PV technology modernization (including automation/AI). It also clarifies why regulator centric tools such as the WHO Global Benchmarking Tool (GBT) do not fully address Marketing Authorisation Holder (MAH) needs. The framework is aligned to GVP/ICH expectations, defines key maturity dimensions and indicative maturity levels, and is supported by illustrative performance indicators and a practical, risk based roadmap to strengthen inspection readiness and drive continuous improvement.
Keywords: pharmacovigilance maturity, safety monitoring systems, regulatory compliance in PV, risk based decision making, drug safety data management
How to Cite?: Udit Mathur, "Pharmacovigilance Maturity Assessment for High-Impact Business Scenarios: A GVP / ICH-Aligned Framework", Volume 15 Issue 4, April 2026, International Journal of Science and Research (IJSR), Pages: 1260-1269, https://www.ijsr.net/getabstract.php?paperid=SR26331170046, DOI: https://dx.dx.doi.org/10.21275/SR26331170046