Potential for use of Al/machine learning for pharmacovigilance: Is there a role for regulators?

Christina Gao; Ashley M. Hopkins; Andrew Rowland; Stephen Bacchi

doi:10.1002/bcp.70173

Potential for use of Al/machine learning for pharmacovigilance: Is there a role for regulators?

Christina Gao, Ashley M. Hopkins, Andrew Rowland, Stephen Bacchi

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Abstract

The vital role of pharmacovigilance may be supported through the strategic use of artificial intelligence (AI). Appropriate regulatory frameworks will be required to fully realize the possible benefits. When considering the role of regulators in this space, it is necessary to reflect on the differing types of AI—such as analytical AI vs. generative AI—and the various ways these may be applied across pharmacovigilance systems. These applications span from enhancing the efficiency of routine workflows to enabling novel insights from large-scale, unstructured datasets.

Original language	English
Number of pages	3
Journal	British Journal of Clinical Pharmacology
DOIs	https://doi.org/10.1002/bcp.70173
Publication status	E-pub ahead of print - 14 Jul 2025

Keywords

pharmacovigilance
artificial intelligence (AI)
machine learning
regulators

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title = "Potential for use of Al/machine learning for pharmacovigilance: Is there a role for regulators?",

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AU - Rowland, Andrew

AU - Bacchi, Stephen

PY - 2025/7/14

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KW - artificial intelligence (AI)

KW - machine learning

KW - regulators

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ER -

Potential for use of Al/machine learning for pharmacovigilance: Is there a role for regulators?

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