Post-Market Surveillance Evolution: Pharmacovigilance 2.0 and the future of global Drug Safety

Pharmacovigilance (PV) plays a critical role in ensuring the safety of drugs and vaccines after marketing authorization. Traditionally, PV systems relied heavily on spontaneous adverse drug reaction (ADR) reporting, which often faced challenges such as underreporting, fragmented data sources, and delays in signal detection. The COVID-19 pandemic highlighted these shortcomings, creating an urgent need for more efficient, technology-driven systems. This led to the emergence of “Pharmacovigilance 2.0,” characterized by the integration of artificial intelligence (AI), real-world evidence (RWE), big data analytics, and digital platforms, including mobile applications, for active and predictive safety surveillance. In India, the Pharmacovigilance Programme of India (PvPI) has strengthened ADR reporting networks, signal detection capabilities, and risk communication mechanisms. Meanwhile, in the United States, the FDA’s Sentinel 2.0 system utilizes advanced analytics to proactively monitor post-market drug safety in near real time. This article explores the evolution of PV systems in both countries, comparing key innovations, highlighting regulatory advancements, identifying existing challenges, and proposing future directions for achieving harmonized, globally efficient drug and vaccine safety frameworks.